(85 days)
Not Found
No
The device description and performance studies focus on mechanical safety features and standard medical device testing, with no mention of AI or ML.
No
Explanation: This device is a port access infusion set designed to administer solutions to a surgically implanted port, and protect against needle stick injuries. It does not actively treat or cure a disease or medical condition.
No
Explanation: The device is described as a port access infusion set used to administer solutions, with features for safety and ease of use. There is no mention of it being used for diagnostic purposes, such as collecting information about a patient's health status.
No
The device description clearly outlines physical components like needles, tubing, clamps, and fittings, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "administer solutions to surgically implanted port." This describes a device used for delivering substances into the body, not for examining specimens from the body to obtain diagnostic information.
- Device Description: The description focuses on the physical components and function of a device for accessing an implanted port and preventing needle sticks. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological specimens.
- Providing diagnostic information about a patient's health status.
- Using reagents or assays.
- Measuring analytes.
The device is clearly described as a medical device used for infusion and port access, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to administer solutions to surgically implanted port.
Product codes (comma separated list FDA assigned to the subject device)
FPA, PTI
Device Description
The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to administer solutions to a surgically implanted port. This device is designed utilizing a non-coring Huber needle to access the implanted port. The K-Shield Advantage PAIS has an integral safety device intended to protect against accidental needle stick injuries and infection caused by blood borne pathogens. Upon removal from the port, the anti-needlestick protector (ANSP) covers the needle tip protecting against accidental needle stick injuries.
The devices are disposable ethylene oxide sterilized medical devices which are constructed from non-coring needle (Huber needle), wing, tubing (either micro bore or standard bore), clamp, female conical fitting and locking cap. The device has optional injection site (needle injection, needleless access connector (NAC), or no injection site) and anti-needle stick protector (ANSP).
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
used primarily in a hospital / healthcare facility setting.
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)
Bench testing was performed and confirms that the device meets design requirements and specifications. The devices comply with the International standard ISO 8536-4:2010-Infustion equipment for medical use -Part 4: Infusion sets for single use, gravity feed [Including: Amendment 1 (2013)] mainly, to be used primarily in a hospital / healthcare facility setting. The devices were evaluated to be safe and effective as a medical device based on design verification test results.
Kawasumi Laboratories, Inc. conducts risk analysis according to the requirements of ISO 14971:2007 Medical Devices-Application of Risk Management to Medical Devices for the modifications to the device. The identified risks were adequately mitigated and verified by means of bench testing.
The device continues to meet the same material testing standards and sterilization process standards as the predicate devices. Device verification testing of performance has been verified through functional and simulate use testing.
Performance Test for Needle Cap Removal Force:
Purpose: The needle cap used for the subject device (modified K-Shield Advantage PAIS) is changed into straw CAP, from T-CAP of predicate device (K123344). In order to make sure that the function of the needle cap has not changed, measurement of cap removal force is performed with the new and old caps.
Method: The removal force was measured when removing the cap by hand from the product fixed on a force gauge.
Sample size: N= 30 for each cap.
Acceptance Criteria: The removal resistance of straw cap is lower than T-cap. (In-house criteria)
Result: Conforms
Discussion and Conclusion: Cap removal force was lower with straw cap compared to T-CAP. Moreover, as per the transportation test already performed there was no cap detachment due to the transportation. As a conclusion, it was confirmed that there was no change in the function of the needle cap due to this modification.
Simulated Use Testing (Sharps Injury Prevention testing):
Method: K-Shield Advantage Port Access Infusion Set includes sharps injury prevention feature (Anti-needle Stick Protector; ANSP). As ANSP of the device was modified, simulated use testing was conducted to evaluate the safety and effectiveness of its function. The test was conducted as per ISO 23908:2011 and FDA Guidance – Medical Device with Sharp Injury Prevention Features.
Result: For all of effective samples (n=599) evaluated, proper activation of ANSP were observed. This result exceeds the pre-defined acceptance criteria. The result confirmed that the anti- needle stick function of the modified K-Shield Advantage PAIS works as safely and effectively as the predicate device.
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.
Not Found
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
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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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 acronym and name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is written in blue letters next to it.
May 2, 2019
Kawasumi Laboratories, Inc. % Valerie Followell Regulatory Affairs Consultant Regulatory Compliance Associates, Inc. 10411 Corporate Drive, Suite 102 Pleasant Prairie, Wisconsin 53158
Re: K190233
Trade/Device Name: K-Shield Advantage Port Access Infusion Set (PAIS) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA, PTI Dated: April 1, 2019 Received: April 4, 2019
Dear Valerie Followell:
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Tina Kiang, Ph.D 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
K-Shield Advantage Port Access Infusion Set (PAIS)
Indications for Use (Describe)
The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to administer solutions to surgically implanted port.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| 5. 510(k) SUMMARY | K190233 |
|---|---|
| DATE: | March 28, 2019 |
| OWNER: | Kawasumi Laboratories, Inc. |
| Shinagawa Intercity Tower B | |
| 2-15-2, Konan, | |
| Minato-ku, Tokyo, JAPAN 108-6109 | |
| CONTACT PERSON: | Valerie Followell |
| Regulatory Affairs Consultant | |
| Regulatory Compliance Associates®, Inc. | |
| 10411 Corporate Drive, Suite 102 | |
| Pleasant Prairie, Wisconsin 53158 | |
| Telephone: 847-400-6187 | |
| Email: v.followell@rcainc.com | |
| DEVICE NAME: | Trade name: K-Shield Advantage Port |
| Access Infusion Set (PAIS) | |
| Common name: Set, IV Fluid Transfer | |
| set, administration, | |
| intravascular | |
| Classification: | |
| Regulation | |
| Number: 21 CFR 880.5440 | |
| Class: Product Class II | |
| Code: FPA | |
| Secondary | |
| Product Code: PTI | |
| PREDICATE DEVICE(S): | Previously cleared 510(k) for Kawasumi |
| Laboratories, Inc., K-Shield Advantage Port Access | |
| Infusion Set |
| Predicate | Device | Indication | Clearance date | Company |
|---|---|---|---|---|
| 510(k) | Name | |||
| K123344 | K-Shield Advantage | |||
| Port Access Infusion | ||||
| Set (PAIS) | a safety port access device | |||
| used to administer solutions | ||||
| to surgically implanted port. | 03/07/2013 | Kawasumi | ||
| Laboratories, Inc. |
4
| DEVICE DESCRIPTION: | The K-Shield Advantage Port Access Infusion Set (PAIS)
is a safety port access device used to administer solutions
to a surgically implanted port. This device is designed
utilizing a non-coring Huber needle to access the implanted
port. The K-Shield Advantage PAIS has an integral safety
device intended to protect against accidental needle stick
injuries and infection caused by blood borne pathogens.
Upon removal from the port, the anti-needlestick protector
(ANSP) covers the needle tip protecting against accidental
needle stick injuries.
The devices are disposable ethylene oxide sterilized
medical devices which are constructed from non-coring
needle (Huber needle), wing, tubing (either micro bore or
standard bore), clamp, female conical fitting and locking
cap. The device has optional injection site (needle
injection, needleless access connector (NAC), or no
injection site) and anti-needle stick protector (ANSP). |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INDICATIONS FOR USE
STATEMENT: | The K-Shield Advantage Port Access Infusion Set (PAIS)
is a safety port access device used to administer solutions
to surgically implanted port. |
| TECHNOLOGICAL
CHARACTERISTICS: | The K-Shield Advantage Port Access Infusion Set (PAIS)
is substantially equivalent to the predicate device with
regard to technological characteristics, performance, and
intended use.
The proposed K-Shield Advantage Port Access Infusion
Set has minor enhancements to the original design of the
predicate device. These modifications include
strengthening the safety device feature, improving gripping
point for easy cannulation and reducing bulkiness of the
needle cap. The modifications do not affect the intended
use of the device or alter the fundamental scientific
technology of the device. |
5
| Features | Subject Device | Predicate Device | ||
|---|---|---|---|---|
| Regulatory | Device Name | K-Shield Advantage Port Access | ||
| Infusion Set (PAIS) | K-Shield Advantage Port Access | |||
| Infusion Set (PAIS) | Same | |||
| 510(k)Number | K190233 | K123344 | Same | |
| Applicant | Kawasumi Laboratories, Inc. | Kawasumi Laboratories, Inc. | Same | |
| Class | 2 | 2 | Same | |
| Product code | FPA, PTI | FPA | Same | |
| C.F.R. Section | 880.5440 | 880.5440 | Same | |
| Intended use | This product is a safety port | |||
| access device used to administer | ||||
| solutions to surgically implanted | ||||
| port. | This product is a safety port | |||
| access device used to administer | ||||
| solutions to surgically implanted | ||||
| port. | Same | |||
| Packaging | Blister rigid tray with heat sealed | |||
| lid | Blister rigid tray with heat sealed | |||
| lid | Same | |||
| Size | Needle Gauge: | |||
| 19G, 20G, 22G | ||||
| Needle Length: | ||||
| 1 inch, 3/4 inch | ||||
| Tube Length: | ||||
| 200mm (w/o NAC), | ||||
| 180mm x 100mm(NAC) | Needle Gauge: | |||
| 19G, 20G, 22G | ||||
| Needle Length: | ||||
| 1 inch, 3/4 inch | ||||
| Tube Length: | ||||
| 200mm (w/o NAC), | ||||
| 180mm x 100mm(NAC) | Same | |||
| Priming volume | ||||
| (mL) | Standard bore : 1.3 | |||
| Micro bore(w/o NAC): 0.4 | ||||
| Micro bore(with NAC): 0.9 | Standard bore : 1.3 | |||
| Micro bore(w/o NAC): 0.4 | ||||
| Micro bore(with NAC): 0.9 | Same | |||
| Needle | Huber Needle | Huber Needle | Same | |
| Connection Luer | Female | Female | Same | |
| Tubing | Standard bore/ Micro bore | Standard bore/ Micro bore | Same | |
| Specification | Antineedle Stick | |||
| Protector (ANSP) | ANSP | |||
| *Minor modification to ANSP | ANSP | Different | ||
| (but | ||||
| equivalent) | ||||
| Injection site | needleless access connector | |||
| (NAC) / none | needleless access connector | |||
| (NAC) / none | Same | |||
| Component & | ||||
| Material | See Table 2 | See Table 2 | Different | |
| (but | ||||
| equivalent) | ||||
| Sterilization | Ethylene Oxide Gas (ETO) | Ethylene Oxide Gas (ETO) | Same | |
| Shelf Life | 3 years | 3 years | Same |
6
| Component | Fluid Path | Material
(Subject device) | Material
(Predicate device K123344) |
|------------|----------------------|-----------------------------------|----------------------------------------|
| Needle | Y | Stainless Steel | Stainless Steel |
| Needle Cap | N | Polyethylene (PE) | Poly-propylene (PP) |
| ANSP Wing | Y
(*Skin contact) | Poly-propylene (PP) | Poly-propylene (PP) |
| Glue | N | Epoxy | Epoxy |
| Hub | Y | Poly-vinyl chloride (PVC) | Poly-vinyl chloride (PVC) |
| Tubing | Y | TOTM Poly-vinyl chloride
(PVC) | TOTM Poly-vinyl chloride
(PVC) |
Table 5-2. Component and Material
ASSESSMENT OF NONCLINICAL DATA:
Bench testing was performed and confirms that the device meets design requirements and specifications. The devices comply with the International standard ISO 8536-4:2010-Infustion equipment for medical use -Part 4: Infusion sets for single use, gravity feed [Including: Amendment 1 (2013)] mainly, to be used primarily in a hospital / healthcare facility setting. The devices were evaluated to be safe and effective as a medical device based on design verification test results.
Kawasumi Laboratories, Inc. conducts risk analysis according to the requirements of ISO 14971:2007 Medical Devices-Application of Risk Management to Medical Devices for the modifications to the device. The identified risks were adequately mitigated and verified by means of bench testing.
The device continues to meet the same material testing standards and sterilization process standards as the predicate devices. Device verification testing of performance has been verified through functional and simulate use testing.
7
| Test item | Standard | Result |
|---|---|---|
| Transportation | ISTA 2A | Pass |
| Packaging test |
- Seal strength
- Dye penetration test | ISO 11607-1:2006(Amd 2014) | Pass |
| Visual inspection | In house standard | Pass |
| Functionality of Anti-needle stick protector | In house standard | Pass |
| Test for tensile strength
(ISO 8536-4) | ISO 8536-4:2010 (Amd 2013) | Pass |
| Test for tensile strength
(In house) | In house standard | Pass |
| Test for tensile Strength
(ISO 7864) *Cannula and hub | ISO 7864:2016 | Pass |
| Leak test | ISO 8536-9:2016 | Pass |
| Chemical test | ISO 8536-4:2010 (Amd. 2013) | Pass |
Table 5-3. List of nonclinical tests
Given the needle cap is not patient contacting, the biocompatibility testing of the modified feature was determined not to be necessary.
| ORMANCE | Modified K-Shield Advantage PAIS products | |
|---|---|---|
| ING CAP | (Evaluation of cap functionality) | |
| OVAL FORCE | Purpose: | The needle cap used for the subject device |
| (modified K-Shield Advantage PAIS) is changed | ||
| into straw CAP, from T-CAP of predicate device | ||
| (K123344). In order to make sure that the | ||
| function of the needle cap has not changed, | ||
| measurement of cap removal force is performed | ||
| with the new and old caps. | ||
| Method: | The removal force was measured when removing | |
| the cap by hand from the product fixed on a | ||
| force gauge. | ||
| Sample size: N= 30 for each cap. | ||
| Acceptance | ||
| Criteria: | The removal resistance of straw cap is lower | |
| than T-cap. | ||
| (In-house criteria) | ||
| Result: | Conforms | |
| Discussion | ||
| and | ||
| Conclusion: | Cap removal force was lower with straw cap | |
| compared to T-CAP. Moreover, as per the | ||
| transportation test already performed there was | ||
| no cap detachment due to the transportation. | ||
| As a conclusion, it was confirmed that there was | ||
| no change in the function of the needle cap due | ||
| to this modification. |
PERFC TESTI REMO
8
| Simulated Use Testing
(Sharps Injury
Prevention testing): | K-Shield Advantage Port Access Infusion Set includes
sharps injury prevention feature (Anti-needle Stick
Protector; ANSP). As ANSP of the device was
modified, simulated use testing was conducted to
evaluate the safety and effectiveness of its function.
The test was conducted as per ISO 23908:2011 and
FDA Guidance – Medical Device with Sharp Injury
Prevention Features. |
|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | For all of effective samples (n=599) evaluated, proper
activation of ANSP were observed. This result exceeds
the pre-defined acceptance criteria. The result
confirmed that the anti- needle stick function of the
modified K-Shield Advantage PAIS works as safely
and effectively as the predicate device. |
| CONCLUSIONS: | The K-Shield Advantage Port Access Infusion Set
(PAIS) is substantially equivalent to the predicate
device. Testing against established standards and
guidelines for its intended use and results of the risk
analysis demonstrate that the proposed device is
substantially equivalent to the predicate device. |