(149 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a prefilled saline syringe, with no mention of AI or ML.
No
The device is described as a flush syringe containing saline solution, intended for maintaining intravenous lines, not for treating a disease or condition itself.
No
The device description and intended use clearly state that it is a syringe prefilled with saline solution for flushing intravenous lines and devices. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (polypropylene syringe, plunger, gasket, etc.) and the performance studies focus on bench testing of these physical attributes and the saline solution, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in flushing compatible intravenous administration sets and indwelling intravenous access devices." This describes a direct interaction with the patient's circulatory system and medical devices used for administering fluids or medications.
- Device Description: The device is a prefilled syringe containing saline solution. This is a medical device used for a therapeutic or procedural purpose (flushing), not for analyzing a sample from the body to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Flush Syringe (Prefilled 0.9% normal saline solution) is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.
Product codes
NGT
Device Description
Flush Syringe (Prefilled 0.9% normal saline solution) is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap. The Flush Syringe (Prefilled 0.9% normal saline solution) consists of barrel, plunger, gasket and thread stopper which is used after the intended purpose is achieved to cover the barrel tip of the device. The Flush Syringe (Prefilled 0.9% normal saline solution) is sterile, non-pyrogenic and for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The non-clinical testing for Flush Syringe (Prefilled 0.9% normal saline solution) was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below. The following performance testing was conducted on the proposed device: Physical testing of syringe, Integrity test of package, Dimension test, Lubricant of syringe test, Dead space test, Limits of acidity or alkalinity of syringe, pH value, Chemical Identification Tests, 0.9% normal saline content test, Oxidizable substance test, Iron test, Ammonium, Calcium, Carbonate, Sulfate, Total organic carbon, Limits of extractable metals, Particulate matter, Bacterial endotoxins test, Acute systemic toxicity, Intra-cutaneous reactivity, Skin sensitization, In vitro cytotoxicity, Material Mediated Pyrogenicity, Genotoxicity (Bacterial Reverse Mutation Test), Implantation, In vitro hemolysis properties, Sealing Strength, Dye Penetration Test, Vacuum decay test. All tests passed their respective acceptance criteria. The shelf life of the final finished sterilized device was evaluated according to the recognized consensus standard ASTM F1980-16 to verify that the subject device will remain within specification during the prescribed shelf life when stored under the labeled storage conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 9, 2023
SPM Medicare Pvt. Ltd. Sanjay Kumar Deputy Manager B-40. Phase II Noida, Gautam Budh Nagar, Uttar Pradesh 201305 India
Re: K231724
Trade/Device Name: Flush Syringe (Prefilled 0.9% normal saline solution) Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: NGT Dated: June 13, 2023 Received: June 13, 2023
Dear Sanjay Kumar:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231724
Device Name
Flush Syringe (Prefilled 0.9% normal saline solution)
Indications for Use (Describe)
Flush Syringe (Prefilled 0.9% normal saline solution) is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Summary K231724
This 510K summary is being prepared in accordance with the requirements of Title 21, CFR Section 807.92.
a) Submitter Information:
- : SPM Medicare Pvt. Ltd Submitter B-40,Phase II Gautam Budh Nagar Noida -201305,Uttar Pradesh, India
- Mr. Umang Mathur Contact Person: Position :Managing Director Tel : +91-971-100-8401 Email:umang@spmmedicare.com
Designation Submission
Correspondent Primary Contact Person:
Sanjay Kumar Position: Deputy Manager-QA & MR Tel: +91-8384011434 Email : sanjay.qa@spmmedicare.com
Date of Preparation : 11-08-2023
b) Device Information:
Trade or Proprietary Name: Common or Usual Name: Classification Name: Product Code: Regulation Number: Device Classification: Review Panel:
Flush Syringe (Prefilled 0.9% normal saline solution) Pre-Filled Normal Saline Flush Syringe Saline, vascular access flush NGT 880.5200 General Hospital
5
Identification of Legally Marketed Device(s): c)
Flush Syringe, 510K number K183473.
d) Device Description:
Flush Syringe (Prefilled 0.9% normal saline solution) is a polypropylene plastic syringe filled with 0.9% sodium chloride for injection, USP, and capped with a polypropylene syringe tip cap. The Flush Syringe (Prefilled 0.9% normal saline solution) consists of barrel, plunger, gasket and thread stopper which is used after the intended purpose is achieved to cover the barrel tip of the device. The Flush Syringe (Prefilled 0.9% normal saline solution) is sterile, non-pyrogenic and for single use.
Indications for Use: e)
Flush Syringe (Prefilled 0.9% normal saline solution) is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.
Technological Characteristics Comparison: f)
Intended use: The subject device has the same intended use as the predicate device.
Comparison between subject device and predicate device.
6
| able | 1
ﮐﺎ
S |
|------|--------------|
| | |
| Device
Characteristic | Subject device | Predicate device
(K183473) | Discussion |
|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Indications
for
Use | The Flush Syringe (Prefilled 0.9%
normal saline solution) is intended
for use in flushing compatible
intravenous administration sets
and indwelling intravenous
access devices. | The AMSafe 0.9% sodium
chloride pre- filled normal
saline flush syringe, is
intended for use in flushing
compatible intravenous
administration sets and
indwelling intravenous access
devices. Use according to the
recommend at ions of the
manufacturer for the
appropriate device. | Identical |
| Operation
Principle | The Flush Syringe (Prefilled 0.9%
normal saline solution) is a three-
piece, sterile, single use syringe
with a 6% (Luer) connector pre-
filled with 0.9% Sodium Chloride
Injection, USP, and sealed with
a tip cap. | The AMSafe® Pre- Filled
Normal Saline Flush Syringe is
a three-piece, sterile, single
use syringe with a 6% (Luer)
connector pre-filled with 0.9%
Sodium Chloride Injection,
USP, and sealed with a tip
сар. | Identical |
| Design | Flush Syringe (Prefilled 0.9%
normal saline solution) with Luer
lock connection fitting and non-
vented, female Luer lock tip cap | Prefilled Normal Saline plastic
piston syringe with Luer lock
connection fitting and non-
vented, female Luer lock tip
cap | Identical |
| Chemical
composition | 0.9% Sodium chloride injection,
USP | 0.9% Sodium chloride
injection, USP | Identical |
| Syringe material | Barrel and plunger:
polypropylene
Stopper: Bromo Butyl rubber
(not made with natural rubber
latex)
Tip cap: polypropylene with
white colorant | Barrel and plunger:
polypropylene
Stopper: Butyl rubber (not
made with natural rubber
latex)
Tip cap: polypropylene with
white colorant | Identical |
| Syringe Size
and Fill
Volumes | Fill 3ml, 5ml, 10ml volume in
10cc syringe | Fill 3ml, 5ml, 10ml volume in
12cc syringe
Fill 20ml volume in 20cc
syringe | Different
(Comment 1) |
| Fill Volume
Graduation | On syringe label | On syringe label | Identical |
| Syringe Content | 0.9% Sodium Chloride Injection,
USP | 0.9% Sodium Chloride
Injection, USP | Identical |
| Syringe
packaging | Polyster & LD ribbon pouch
Sterile barrier | PP wrap or Sterile barrier
Plastic peel pouch | Different
(Comment 2) |
| Sterile | Yes | Yes | Identical |
| Device with
Fluid path only
sterile
Or
Device provided
sterile | Device with Fluid path only
sterile
and
Device provided sterile | Device with Fluid path only
sterile
Or
Device provided sterile | Identical |
| Sterilization
method and
SAL Level | Terminally sterilized by Gamma
radiation, 10-6 SAL | Terminally sterilized by
Gamma radiation, 10-6 SAL | Similar |
| Labeled non-
pyrogenic | Yes | Yes | Identical |
| Single use
only | Yes | Yes | Identical |
| Shelf Life | 3 years | 2 years | Different
(Comment 3) |
| Content of
Syringe
Package | One syringe per pouch | One syringe per pouch | Identical |
7
Comment 1: The subject device has range 3ml, 5ml & 10 ml which is similar to predicate device, predicate device has additionally Fill 20ml volume in 20cc syringe, the device capacity is based on device intended use, it does not impact intended use. Fill volume according to the market needs.
Comment 2: Subjective device has different pouch packing with comparison of predicate device, package integrity tests is conducted, different pack size does not impact on intended usage of product.
Comment 3: Subjective device has 3 years shelf life while predicate device has 2 years; stability study is conducted to justify the shelf life. It does not impact the intended usage and product Quality.
g) Summary of Non-clinical Testing (Bench):
The non-clinical testing for Flush Syringe (Prefilled 0.9% normal saline solution) was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards shown below.
The following performance testing was conducted on the proposed device:
8
| ID# | Test | Method | Acceptance criteria | Conclusion |
|---|---|---|---|---|
| 1 | Physical testing of syringe | ISO 7886-1, ISO | ||
| 11040-8, ISO | ||||
| 80369-7 | ISO7886-1 ISO80369-7 | Pass | ||
| Integrity test of package | ASTM F2338-09 | No leakage | Pass | |
| Dimension test | ISO 80369-7 | ISO80369-7 | Pass | |
| Lubricant of syringe test | ISO 7886-1 | ISO7886-1 | Pass | |
| Dead space test | ISO 7886-1 | ISO7886-1 | Pass | |
| Limits of acidity or | ||||
| alkalinity of syringe | ISO 7886-1 | ISO7886-1 | Pass | |
| Sodium Chloride Injection, USP Testing | ||||
| pH value | USP | PH: 4.5-7.0 | Pass | |
| Chemical Identification | ||||
| Tests | USP | USP | Pass | |
| 0.9% normal saline | ||||
| content test | USP 6-466 | 0.86% - 0.94% | Pass | |
| Oxidizable substance test | VP200 | VP200 | Pass | |
| 2 | Iron test | USP | USP | |
| Calcium | USP | USP | Pass | |
| Carbonate | USP | USP | Pass | |
| Sulfate | USP | USP | Pass | |
| Total organic carbon | USP | USP | Pass | |
| Limits of extractable | ||||
| metals | USP | |||
| USP | USP USP | Pass | ||
| 3 | Particulate matter | USP | ≥10um, ≤6000 | |
| ≥25um, ≤600 | ||||
| Biocompatibility testing: | ||||
| 4 | Bacterial endotoxins test | USP | Bacterial | |
| endotoxins≤0.5EU/mL | Pass | |||
| Acute systemic toxicity | ISO10993-11 | No acute systemic | ||
| toxicity | Pass | |||
| Intra-cutaneous reactivity | ISO10993-10 | Non-irritant | Pass | |
| Skin sensitization | ISO10993-10 | Non-sensitizer | Pass | |
| In vitro cytotoxicity | ISO10993-5 | Non-cytotoxic | Pass | |
| Material Mediated | ||||
| Pyrogenicity | ISO 10993-11 | No pyrogenicity | Pass | |
| Genotoxicity (Bacterial | ||||
| Reverse Mutation Test) | ISO 10993-3 | No Genotoxicity | Pass | |
| Implantation | ISO 10993-6 | No evidence of local | ||
| tissue effects | Pass | |||
| In vitro hemolysis | ||||
| properties | ASTM F756-17 | Non-hemolytic | Pass | |
| 5. | Package Integrity Test | |||
| Sealing Strength | ASTM F88/F88M and | |||
| EN 868-5 | Should not be less than | |||
| 1.2N | Pass | |||
| Dye Penetration Test | ASTM F 1929 | Should be no evidence of | ||
| leakage | Pass | |||
| Vacuum decay test | ASTM F 2338 | There should be no water | ||
| present inside the pouch | Pass |
Table 5-2
9
The shelf life of the final finished sterilized device was evaluated according to the recognized consensus standard ASTM F1980-16 to verify that the subject device will remain within specification during the prescribed shelf life when stored under the labeled storage conditions.
h) Conclusions:
The conclusions drawn from the nonclinical tests demonstrate that the Flush Syringe (Prefilled 0.9% normal saline solution) is as safe, as effective, and performs as well as or better than the legally marketed predicate device.