(60 days)
No
The summary describes a mechanical IV catheter with safety features and does not mention any AI or ML components or functionalities.
No.
The device is used for administering fluids, monitoring blood pressure, or sampling blood, not for treating a disease or condition.
No
The device is described as an IV catheter for administering fluids, sampling blood, and monitoring blood pressure, which are functions related to treatment and monitoring, not diagnosis. While blood sampling can be part of diagnostic procedures, the device itself doesn't perform diagnostic analysis.
No
The device description clearly states it is an "over-the-needle, peripheral safety IV catheter," which is a physical hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for insertion into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids. These are all procedures performed on the patient, not on a sample of bodily fluid outside the body for diagnostic purposes.
- Device Description: The description details an over-the-needle catheter designed for vascular access. This aligns with the intended use of accessing the vascular system directly.
- Lack of IVD Characteristics: There is no mention of analyzing a sample of blood or other bodily fluid to provide diagnostic information about a patient's condition. IVDs are typically used to detect, measure, or identify substances in a sample to aid in diagnosis, monitoring, or screening.
Therefore, the Polyshield and Polyguard Safety IV Catheters are medical devices used for therapeutic and monitoring purposes within the patient's vascular system, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Polyshield and Polyguard Safety IV Catheters are indicated for short term use (less than 30 days) for insertion into a patient's vascular system to sample blood pressure, or administer fluids. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The 14 - 24G catheters may be used intravascularly with power injectors at a maximum pressure of 300 ps.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
The Polyshield and Polyguard Safety IV Catheters are over-the-needle, peripheral safety IV catheters that incorporate an active sharps prevention needle shield. The 'BC' versions also incorporate a blood control feature, and the 'Adva' versions include 'quick flash back' needle technology. The devices are available in multiple gauge sizes and lengths. In more detail:
- Polyshield: An over-the-needle, peripheral active safety IV catheter that incorporates a springactivated needle shield to help prevent needle-stick injuries
- Polyshield Adva: An over-the-needle, peripheral active safety IV catheter that incorporates a springactivated needle shield to help prevent needle-stick injuries. The device is also provided with quick flash back (Adva needle) technology. Instant confirmation of blood flow along catheter body increases clinician's ability to successfully access the vein.
- Polyshield BC: An over-the-needle, peripheral active safety IV catheter with wings that incorporates a spring-activated needle shield to help prevent needle-stick injuries, together with a blood control feature that prevents blood flow until a distal connection is made.
- An over-the-needle, peripheral active safety IV catheter with wings that incorporates Polyshield BC Adva: a spring-activated needle shield to help prevent needle-stick injuries, together with a blood control feature that prevents blood flow until a distal connection is made. The device is also provided with quick flash back (Adva needle) technology. Instant confirmation of blood flow along catheter body increases clinician's ability to successfully access the vein.
- An over-the-needle, peripheral active safety IV catheter that incorporates a push-Polyquard+: back needle shield to help prevent needle-stick injuries.
- Polyguard+ Adva: An over-the-needle, peripheral active safety IV catheter that incorporates a pushback needle shield to help prevent needle-stick injuries. The device is also provided with quick flash back (Adva needle) technology. Instant confirmation of blood flow along catheter body increases clinician's ability to successfully access the vein.
- An over-the-needle, peripheral active safety IV catheter with wings that incorporates Polyguard BC: a push-back needle shield to help prevent needle-stick injuries, together with a blood control feature that prevents blood flow until a distal connection is made
- Polyguard BC Adva: An over-the-needle, peripheral active safety IV catheter with wings that incorporates a push-back needle shield to help prevent needle-stick injuries, together with a blood control feature that prevents blood flow until a distal connection is made. The device is also provided with quick flash back (Adva needle) technology. Instant confirmation of blood flow along catheter body increases clinician's ability to successfully access the vein.
Color-coding of the catheter hub (and wings, where fitted) is used to help identify the catheter gauge size, in accordance with ISO 10555-5.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
Indicated Patient Age Range
any patient population
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing of the Polyshield and Polyguard Safety IV Catheters has included successful compliance testing with the following standards, most of which are FDA-recognized:
- ISO 10555-1:2013/AMD 1:2017, FDA recognition # 6-408
- ISO 10555-5:2013, FDA recognition # 6-303
- ISO 80369-7:2021, FDA recognition # 5-115
- ISO 11135:2014/AMD 1:2019, FDA recognition #14-529
- ISO 11607-2:2019, FDA recognition # 14-531
- ISTA 3A transportation test
- ASTM 640-20, FDA recognition # 8-556
- USP Method 1
- Blood sample collection times, for applicable devices
Biocompatibility of components in direct contact with the patient has been established by testing in accordance with the matrix included in Annex A of ISO 10993-1:2018, while taking into consideration relevant FDA quidance, according to which the subject device components are externally communicating items in either prolonged direct contact with circulating blood or indirect contact with the blood path. The tests undertaken were:
- Cytotoxicity (ISO 10993-5:2009, FDA recognition # 2-245)
- Sensitization (ISO 10993-10:2010, FDA recognition # 2-174)
- Irritation or intracutaneous reactivity (ISO 10993-10:2010, FDA recognition # 2-174)
- Acute systemic toxicity (ISO 10993-11:2017, FDA recognition # 2-255)
- Subacute/subchronic toxicity (ISO 10993-11:2017, FDA recognition # 2-255)
- Material mediated pyrogenicity (ISO 10993-11:2017, FDA recognition # 2-255)
- Hemocompatibility (ISO 10993-4:2017, FDA recognition # 2-248)
- Implantation (ISO 10993-6:2016, FDA recognition # 2-247)
- Genotoxicity (ISO 10993-3:2014, FDA recognition # 2-228)
A shelf life of 3 or 5 years, depending on the specific model, has been established by testing the integrity of the sterile packaging following accelerated aging (per ASTM F 1980-16) in accordance with the following standards:
- ISO 10555-1:2013/AMD 1:2017. FDA recognition # 6-408
- ISO 10555-5:2013, FDA recognition # 6-303
- ISO 80369-7:2016, FDA recognition # 5-115
- USP Method 1
- USP
- USP
- ASTM F-1929, FDA recognition # 14-484
- ASTM F-2096, FDA recognition # 14-359
- ASTM F-88 / F-88M, FDA recognition # 14-573
A clinical simulation study has also been carried out in accordance with ISO 23908:2011, while taking into consideration relevant FDA guidance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
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May 5, 2023
Poly Medicure Limited % Roger Gray VP Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania 10 Rome, 00153 Italy
Re: K230616
Trade/Device Name: Polyguard and Polyshield Safety IV Catheters Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: March 1, 2023 Received: March 7, 2023
Dear Roger Gray:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Walloschek
David Wolloscheck, Ph.D. Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Polyguard and Polyshield Safety IV Catheters
Indications for Use (Describe)
The Polyshield and Polyguard Safety IV Catheters are indicated for short term use (less than 30 days) for insertion into a patient's vascular system to sample blood pressure, or administer fluids. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The 14 - 24G catheters may be used intravascularly with power injectors at a maximum pressure of 300 ps.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K230616 - 510(k) Summary
| Type of 510(k) submission: | Traditional |
|---|---|
| Date of Preparation: | 3 May 2023 |
| Manufacturer: | Poly Medicure Ltd |
| Plot No. 115-117, Sector- 59 | |
| HSIIDC Industrial Area, Ballabgarh | |
| Faridabad-121004, Haryana, INDIA | |
| Phone: | +91-129-3355070 |
| 510(k) Owner and Submitter: | Poly Medicure Ltd |
| Plot No. 115-117, Sector- 59 | |
| HSIIDC Industrial Area, Ballabgarh | |
| Faridabad-121004, Haryana, INDIA | |
| 510(k) Contact: | Mr. Roger Gray |
| VP Quality and Regulatory | |
| Donawa Lifescience Consulting | |
| Piazza Albania 10 | |
| 00153 Rome, ITALY | |
| Phone: | |
| Email: | +39 06 578 2665 |
| rgray@donawa.com | |
| Subject Device Trade Name: | Polyguard and Polyshield Safety IV Catheters |
| Common Name: | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Requlation Number: | 21 CFR 880.5200 |
| Regulation Name: | Intravascular catheter |
| Product Code: | FOZ |
| Classification Panel: | General Hospital |
| Predicate Device: | |
| Sponsor | |
| 510(k) Number | |
| Clearance Date: | |
| FDA Product Code | |
| Regulation No: | |
| Regulation Name | |
| Class: | BD Insyte Autoguard BC |
| Becton Dickinson Infusion Therapy Systems Inc | |
| K110443 | |
| 19 July 2011 | |
| FOZ | |
| 21 CFR 880.5200 | |
| Intravascular catheter | |
| II | |
| . |
A reference device has been identified as being relevant to this submission, this being:
| Reference Device: | ViaValve Safety IV Catheter |
|---|---|
| Sponsor | Smiths Medical ASD, Inc. |
| 510(k) Number | K160235 |
| Clearance Date: | 30 June 2016 |
| FDA Product Code | FOZ |
| Regulation No: | 21 CFR 880.5200 |
| Regulation Name: | Intravascular catheter |
| Class: | II |
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Indications for Use:
The Polyshield and Polyguard Safety IV Catheters are indicated for short term use (less than 30 days) for insertion into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The 14 - 24G catheters may be used intravascularly with power injectors at a maximum pressure of 300 psi.
Device Description:
The Polyshield and Polyguard Safety IV Catheters are over-the-needle, peripheral safety IV catheters that incorporate an active sharps prevention needle shield. The 'BC' versions also incorporate a blood control feature, and the 'Adva' versions include 'quick flash back' needle technology. The devices are available in multiple gauge sizes and lengths. In more detail:
- Polyshield: An over-the-needle, peripheral active safety IV catheter that incorporates a springactivated needle shield to help prevent needle-stick injuries
- Polyshield Adva: An over-the-needle, peripheral active safety IV catheter that incorporates a springactivated needle shield to help prevent needle-stick injuries. The device is also provided with quick flash back (Adva needle) technology. Instant confirmation of blood flow along catheter body increases clinician's ability to successfully access the vein.
- Polyshield BC: An over-the-needle, peripheral active safety IV catheter with wings that incorporates a spring-activated needle shield to help prevent needle-stick injuries, together with a blood control feature that prevents blood flow until a distal connection is made.
- An over-the-needle, peripheral active safety IV catheter with wings that incorporates Polyshield BC Adva: a spring-activated needle shield to help prevent needle-stick injuries, together with a blood control feature that prevents blood flow until a distal connection is made. The device is also provided with quick flash back (Adva needle). Instant confirmation of blood flow along catheter body increases clinician's ability to successfully access the vein.
- An over-the-needle, peripheral active safety IV catheter that incorporates a push-Polyquard+: back needle shield to help prevent needle-stick injuries.
- Polyguard+ Adva: An over-the-needle, peripheral active safety IV catheter that incorporates a pushback needle shield to help prevent needle-stick injuries. The device is also provided with quick flash back (Adva needle) technology. Instant confirmation of blood flow along catheter body increases clinician's ability to successfully access the vein.
- An over-the-needle, peripheral active safety IV catheter with wings that incorporates Polyguard BC: a push-back needle shield to help prevent needle-stick injuries, together with a blood control feature that prevents blood flow until a distal connection is made
- Polyguard BC Adva: An over-the-needle, peripheral active safety IV catheter with wings that incorporates a push-back needle shield to help prevent needle-stick injuries, together with a blood control feature that prevents blood flow until a distal connection is made. The device is also provided with quick flash back (Adva needle) technology. Instant confirmation of blood flow along catheter body increases clinician's ability to successfully access the vein.
Color-coding of the catheter hub (and wings, where fitted) is used to help identify the catheter gauge size, in accordance with ISO 10555-5.
The major features of the available models are indicated in Table 1.
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| Table 1: Polyshield and Polyguard major design features | ||||||||
|---|---|---|---|---|---|---|---|---|
| Feature | Polyshield | Polyshield | ||||||
| Adva | Polyshield | |||||||
| BC | Polyshield | |||||||
| BC Adva | Polyguard+ | Polyguard+ | ||||||
| Adva | Polyguard | |||||||
| BC | Polyguard | |||||||
| BC Adva | ||||||||
| Safety | ||||||||
| mechanism | ||||||||
| type | Active | Active | Active | Active | Active | Active | Active | Active |
| Spring | ||||||||
| activated by | ||||||||
| button | Yes | Yes | Yes | Yes | No | No | No | No |
| Push-back | ||||||||
| mechanism | No | No | No | No | Yes | Yes | Yes | Yes |
| Blood | ||||||||
| control | ||||||||
| mechanism | No | No | Yes | Yes | No | No | Yes | Yes |
| Quick flash | ||||||||
| back | No | Yes | No | Yes | No | Yes | No | Yes |
| Hub wings | Optional | Optional | Optional | Optional | Optional | Optional | Optional | Optional |
| Shelf life of | ||||||||
| device | 3 yrs | 3 yrs | 3 yrs | 3 yrs | 5 yrs | 5 yrs | 3 yrs | 3 yrs |
Polyshield and Polyguard Safety IV Catheters are labeled for prescription use only (Rx only) and supplied sterile for single use with a sterility assurance level (SAL) of 10-6. Sterilization is achieved by ethylene oxide gas exposure.
Technological Characteristics: comparison with Predicate Device:
The following Table 2 provides evidence of substantial equivalence of the subject device with the selected predicate device, while taking into account certain specific features of the reference devices:
| Feature | Subject device
K230616 | Predicate device
K110443 | Similarity |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | Polyguard and Polyshield
Safety IV Catheters | BD Insyte Autoguard BC IV
Catheter | N/A |
| Device
Manufacturer | Poly Medicure, India | Becton Dickinson Infusion
Therapy Systems Inc, USA | N/A |
| FDA Product
Code | FOZ | FOZ | Same |
| FDA
Classification
Name | Catheter, Intravascular,
Therapeutic, Short-Term Less
Than 30 Days | Catheter, Intravascular,
Therapeutic, Short-Term Less
Than 30 Days | Same |
| FDA Regulation
Number | 880.5200 | 880.5200 | Same |
| Device
description: | Polyshield: Over-the-needle,
peripheral safety IV catheter
that incorporates a spring-
activated needle shield
Polyguard: Over-the-needle,
peripheral safety IV catheter
that incorporates a push-back
needle shield
'BC' models: Incorporate a
blood control feature | Over-the-needle, peripheral
safety IV catheter that
incorporates a spring-activated
needle shield and blood control
feature | Substantially equivalent but
without the blood control
feature Note 1
Substantially equivalent to
predicate, but without the blood
control feature and with a push
back safety mechanism instead
of spring-activated safety
mechanism
Polyshield BC identical to
predicate; Polyguard model
substantially equivalent to
predicate but with push back
safety mechanism |
| Table 2: Predicate device comparison table | | | |
| Feature | Subject device
K230616 | Predicate device
K110443 | Similarity |
| | 'Adva' models: Incorporate a
'quick flash back' feature | | 'Adva' models identical to
predicate which includes a
'quick flash back' feature (BD
Instaflash™ needle technology)
on 20, 22 and 24G needles |
| Indications for
use | The Polyshield and Polyguard
Safety IV Catheters are
indicated for short term use
(less than 30 days) for
insertion into a patient's
vascular system to sample
blood, monitor blood pressure,
or administer fluids. The
catheters may be used for any
patient population with
consideration given to patient
size, appropriateness for the
solution being infused, and
duration of therapy. The 14 -
24G catheters may be used
intravascularly with power
injectors at a maximum
pressure of 300 psi. | The BD Insyte Autoguard BC
catheter is inserted into a
patient's vascular system to
sample blood, monitor blood
pressure, or administer fluids. | Substantially equivalent, but
with the addition of patient
population details and power
injector use for the subject
device Note 5 |
| Sharps injury
protection
feature? | Yes - active, tested in
accordance with ISO 23908
and FDA 'Guidance for
Industry and FDA Staff
Medical Devices with Sharps
Injury Prevention Features',
August 2005. | Yes - active | Same |
| Sharps injury
prevention
mechanism | Polyshield and Polyshield BC:
User-activated button initiates
needle retraction into the
needle-shielding barrel. Once
the button has been pushed
and the needle retracted, the
user cannot override the
shielding mechanism to re-
expose the needle tip. | User-activated button initiates
needle retraction into the
needle-shielding barrel. Once
the button has been pushed
and the needle retracted, the
user cannot override the
shielding mechanism to re-
expose the needle tip. | Same |
| | Polyguard and Polyguard BC:
User-activated push-back
mechanism retracts the needle
into the needle-shielding
barrel. Once activated, the
user cannot override the
shielding mechanism to re-
expose the needle tip. | | Different.
Push-back mechanism on
subject device instead of push
button-activated spring
mechanism on predicate Note 2 |
| Catheter tube
material | Polyurethane | Polyurethane | Same |
| X-ray visible | Yes | Yes | Same |
| Needle material | Stainless steel | Stainless steel | Same |
| Needle distal end
configuration | Back cut ground beveled
needle | Back cut ground beveled
needle | Same |
| Flashback
visualization | Adva models | Yes | Same for Adva models |
| Blood control | Yes, in BC models | Yes | Same |
| Table 2: Predicate device comparison table | | | |
| Feature | Subject device
K230616 | Predicate device
K110443 | Similarity |
| Gauge sizes | 14 - 26G | 16 - 24G | Similar Note 3 |
| Color-coding | Yes, according to ISO
10555-5 | Yes, according to ISO
10555-5 | Same |
| Proximal end
configuration | Female 6 % Luer | Female 6 % Luer | Same |
| Single use | Yes | Yes | Same |
| Sterile | Yes, SAL 10-6 | Yes, SAL 10-6 | Same |
| Sterilization
method | Ethylene oxide | Ethylene oxide | Same |
| Shelf life | 3 or 5 years, depending on
model | 3 years | Similar Note 4 |
| Physical
properties | According to ISO 10555-1, ISO
10555-5 | Unknown | N/A |
| Power injection
usage? | Yes, 14 - 24G catheters up to
300 psi. | No | Different Note 5 |
| Biocompatibility | Biocompatible in accordance
with ISO 10993 series and
FDA guidance | Biocompatible in accordance
with ISO 10993 series | Same |
| Particulates | Complies with USP | Not indicated | Different Note 6 |
| Environment of
use | Rx only | Rx only | Same |
| Hub wings? | Yes, as an option | Yes, as an option | Same |
| MR compatibility | MR Conditional | Not indicated | Different Note 7 |
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Image /page/6/Picture/0 description: The image is a logo for a company called "Polymed Medical Devices". The logo features the company name in teal letters, with a yellow circle containing a red cross in the center of the "O" in "Polymed". Below the company name is the tagline "We Care As We Cure" in a smaller, teal font. The logo is simple and professional, and the colors are eye-catching.
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The subject device and the predicate device have many identical, similar or substantially equivalent properties or features. The differences that exist and are identified in the above table are explained in further detail in the following paragraphs.
Note 1: Blood control feature: The subject device does not include a 'blood contro' feature in the range, whereas the predicate device does offer this in all models in the range. The non-availability of a blood control feature on some models in the subject device range does not raise new questions of safety or efficacy.
Note 2: Safety mechanism: The subject device range offers both a 'click to close' and a 'push back to close' option, depending on the model type, whereas the predicate device offers only a 'click to close' option. The reference device, however, offers the 'push back to close' option, and the subject device has been subjected to the same simulated clinical use test regime, in accordance with FDA 'Guide for Industry and staff – Medical Devices with Sharp injury Prevention Features' and ISO 23908:2011. Use of the 'push back to close' mechanism on certain models of the subject device range does not raise new questions of safety or efficacy.
Note 3: Gauge sizes in range: The subject device includes a wider range of gauge sizes than the predicate device. "Worst case' samples from the subject device range have been tested and found to be in compliance with ISO 80369-7, ISO 10555-1 and ISO 10555-5. On the basis of these tests, no new questions of safety or efficacy are raised by the inclusion of additional gauge sizes in the subject device range.
Note 4: Shelf life: Certain models of the subject device range have a different shelf life from the devices in the predicate device range. Packaging samples from the subject device range with a longer labeled shelf life (5 years) than the predicate device range (3 years) have been successfully subjected to testing in accordance with ASTM F-1929, ASTM F-2096, and ASTM F-88/F-88M, with no new questions of safety or efficacy being raised.
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Image /page/8/Picture/0 description: The image shows the logo for Polymed Medical Devices. The logo is teal and features a red cross inside of a yellow circle. Below the logo is the tagline "We Care As We Cure".
Note 5: Power injection usage: The subject device catheters in the range 14 - 24G have been verified for use with power injectors up to 300 psi, similar to the reference device, which has been verified for the same power injector pressure for catheters in the 18 - 24G range. Verification of subject device and reference device suitability for power injection was established by successful testing in accordance with ISO 10555-1, with no new questions of safety or efficacy being raised.
Note 6: Particulates: The predicate device was not tested for particulates in accordance with USP , but the subject device has been tested and meets the requirements of this test protocol. The subject device therefore has a lower risk associated with particulate inclusion than the predicate device.
Note 7: Metal slip ring material / MR compatibility: The predicate device is not labelled with respect to its compatibility with magnetic resonance (MR) systems. The reference device includes a similarly sized stainless steel type 305 insert (identified as an 'eyelet actuator') as a slip ring in the subject device. The reference device is identified on www.mrisafety.com as being suitable for labeling as an 'MR Conditional' device, so the subject device has also been labeled 'MR Conditional' as a result of the similarity between the components of interest in each device, thus no new questions of safety or efficacy are raised.
Performance data:
Non-clinical testing of the Polyshield and Polyguard Safety IV Catheters has included successful compliance testing with the following standards, most of which are FDA-recognized:
- ISO 10555-1:2013/AMD 1:2017, FDA recognition # 6-408 ●
- ISO 10555-5:2013, FDA recognition # 6-303 ●
- ISO 80369-7:2021, FDA recognition # 5-115
- ISO 11135:2014/AMD 1:2019, FDA recognition #14-529 ●
- ISO 11607-2:2019, FDA recognition # 14-531
- ISTA 3A transportation test ●
- ASTM 640-20, FDA recognition # 8-556 .
- USP Method 1
- Blood sample collection times, for applicable devices .
Biocompatibility of components in direct contact with the patient has been established by testing in accordance with the matrix included in Annex A of ISO 10993-1:2018, while taking into consideration relevant FDA quidance, according to which the subject device components are externally communicating items in either prolonged direct contact with circulating blood or indirect contact with the blood path. The tests undertaken were:
- Cytotoxicity (ISO 10993-5:2009, FDA recognition # 2-245) ●
- Sensitization (ISO 10993-10:2010, FDA recognition # 2-174) ●
- Irritation or intracutaneous reactivity (ISO 10993-10:2010, FDA recognition # 2-174) .
- Acute systemic toxicity (ISO 10993-11:2017, FDA recognition # 2-255) ●
- . Subacute/subchronic toxicity (ISO 10993-11:2017, FDA recognition # 2-255)
- Material mediated pyrogenicity (ISO 10993-11:2017, FDA recognition # 2-255)
- Hemocompatibility (ISO 10993-4:2017, FDA recognition # 2-248) .
- Implantation (ISO 10993-6:2016, FDA recognition # 2-247)
- Genotoxicity (ISO 10993-3:2014, FDA recognition # 2-228) .
A shelf life of 3 or 5 years, depending on the specific model, has been established by testing the integrity of the sterile packaging following accelerated aging (per ASTM F 1980-16) in accordance with the following standards:
- . ISO 10555-1:2013/AMD 1:2017. FDA recognition # 6-408
- ISO 10555-5:2013, FDA recognition # 6-303 ●
- ISO 80369-7:2016, FDA recognition # 5-115 ●
- USP Method 1
- USP ●
- USP ●
- ASTM F-1929, FDA recognition # 14-484
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Image /page/9/Picture/0 description: The image shows the logo for Polymed Medical Devices. The logo is teal and features a yellow circle with a red cross in the center. Below the logo is the tagline "We Care As We Cure".
- ASTM F-2096, FDA recognition # 14-359 ●
- ASTM F-88 / F-88M, FDA recognition # 14-573 ●
A clinical simulation study has also been carried out in accordance with ISO 23908:2011, while taking into consideration relevant FDA guidance.
Clinical Data:
Not applicable.
Conclusion:
The subject and predicate devices have similar indications for use and fundamental technological characteristics. Any differences in technological characteristics between subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device.