(85 days)
The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to administer solutions to surgically implanted port.
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).
The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety device used to administer solutions to surgically implanted ports. The device was modified from a previously cleared version (K123344), with minor enhancements to strengthen the safety device feature, improve the gripping point for easy cannulation, and reduce the bulkiness of the needle cap.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Nonclinical Bench Tests | ||
| Transportation | Pass (ISTA 2A) | Pass |
| Packaging test - Seal strength | Pass (ISO 11607-1:2006 (Amd 2014)) | Pass |
| Packaging test - Dye penetration test | Pass (ISO 11607-1:2006 (Amd 2014)) | Pass |
| Visual inspection | Pass (In-house standard) | Pass |
| Functionality of Anti-needle stick protector (ANSP) | Pass (In-house standard) | Pass |
| Test for tensile strength (ISO 8536-4) | Pass (ISO 8536-4:2010 (Amd 2013)) | Pass |
| Test for tensile strength (In-house) | Pass (In-house standard) | Pass |
| Test for tensile Strength (ISO 7864) *Cannula and hub | Pass (ISO 7864:2016) | Pass |
| Leak test | Pass (ISO 8536-9:2016) | Pass |
| Chemical test | Pass (ISO 8536-4:2010 (Amd. 2013)) | Pass |
| Needle Cap Evaluation (Cap functionality) | ||
| Cap Removal Force | The removal resistance of straw cap is lower than T-cap (In-house criteria). (No cap detachment during transportation). | Conforms (Lower force for straw cap; no detachment during transportation). |
| Simulated Use Testing (Sharps Injury Prevention) | Proper activation of ANSP for effective samples. (Implied: Meets or exceeds the pre-defined acceptance criteria). | For all effective samples (n=599), proper activation of ANSP was observed. This result exceeds the pre-defined acceptance criteria. |
2. Sample Size and Data Provenance (Test Set):
- Needle Cap Evaluation: N=30 for each cap type (straw cap and T-cap). The data provenance is not explicitly stated but is implicitly from bench testing conducted by Kawasumi Laboratories, Inc.
- Simulated Use Testing: N=599 "effective samples." Data provenance is from simulated use testing conducted by Kawasumi Laboratories, Inc.
3. Number of Experts used to establish the ground truth for the test set and their qualifications:
This information is not provided in the document. The tests performed are primarily bench and simulated use tests based on established international and in-house standards, not expert assessments of performance.
4. Adjudication method for the test set:
This information is not applicable as the tests are objective measurements against defined criteria, not subjective human assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (infusion set), not an imaging or diagnostic AI device that would typically involve human readers.
6. Standalone (algorithm only without human-in-the-loop performance) study:
No, a standalone study was not done. This refers to algorithmic performance, which is not relevant for a physical medical device. The "standalone" concept applies to AI/software as a medical device (SaMD).
7. Type of ground truth used (test set):
The "ground truth" for the test set is established by objective technical standards and in-house criteria for physical performance characteristics (e.g., tensile strength, leak test, cap removal force) and functional activation (ANSP). For the simulated use testing, the ground truth is the observable proper activation of the ANSP.
8. Sample size for the training set:
This information is not applicable. This device is a physical product, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set for a physical medical device.
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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
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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
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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 B2-15-2, Konan,Minato-ku, Tokyo, JAPAN 108-6109 |
| CONTACT PERSON: | Valerie FollowellRegulatory Affairs ConsultantRegulatory Compliance Associates®, Inc.10411 Corporate Drive, Suite 102Pleasant Prairie, Wisconsin 53158Telephone: 847-400-6187Email: v.followell@rcainc.com |
| DEVICE NAME: | Trade name: K-Shield Advantage PortAccess Infusion Set (PAIS)Common name: Set, IV Fluid Transferset, administration,intravascularClassification:RegulationNumber: 21 CFR 880.5440Class: Product Class IICode: FPASecondaryProduct Code: PTI |
| PREDICATE DEVICE(S): | Previously cleared 510(k) for KawasumiLaboratories, Inc., K-Shield Advantage Port AccessInfusion Set |
| Predicate | Device | Indication | Clearance date | Company |
|---|---|---|---|---|
| 510(k) | Name | |||
| K123344 | K-Shield AdvantagePort Access InfusionSet (PAIS) | a safety port access deviceused to administer solutionsto surgically implanted port. | 03/07/2013 | KawasumiLaboratories, Inc. |
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| DEVICE DESCRIPTION: | The K-Shield Advantage Port Access Infusion Set (PAIS)is a safety port access device used to administer solutionsto a surgically implanted port. This device is designedutilizing a non-coring Huber needle to access the implantedport. The K-Shield Advantage PAIS has an integral safetydevice intended to protect against accidental needle stickinjuries and infection caused by blood borne pathogens.Upon removal from the port, the anti-needlestick protector(ANSP) covers the needle tip protecting against accidentalneedle stick injuries.The devices are disposable ethylene oxide sterilizedmedical devices which are constructed from non-coringneedle (Huber needle), wing, tubing (either micro bore orstandard bore), clamp, female conical fitting and lockingcap. The device has optional injection site (needleinjection, needleless access connector (NAC), or noinjection site) and anti-needle stick protector (ANSP). |
|---|---|
| INDICATIONS FOR USESTATEMENT: | The K-Shield Advantage Port Access Infusion Set (PAIS)is a safety port access device used to administer solutionsto surgically implanted port. |
| TECHNOLOGICALCHARACTERISTICS: | The K-Shield Advantage Port Access Infusion Set (PAIS)is substantially equivalent to the predicate device withregard to technological characteristics, performance, andintended use.The proposed K-Shield Advantage Port Access InfusionSet has minor enhancements to the original design of thepredicate device. These modifications includestrengthening the safety device feature, improving grippingpoint for easy cannulation and reducing bulkiness of theneedle cap. The modifications do not affect the intendeduse of the device or alter the fundamental scientifictechnology of the device. |
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| Features | Subject Device | Predicate Device | ||
|---|---|---|---|---|
| Regulatory | Device Name | K-Shield Advantage Port AccessInfusion Set (PAIS) | K-Shield Advantage Port AccessInfusion 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 portaccess device used to administersolutions to surgically implantedport. | This product is a safety portaccess device used to administersolutions to surgically implantedport. | Same | |
| Packaging | Blister rigid tray with heat sealedlid | Blister rigid tray with heat sealedlid | Same | |
| Size | Needle Gauge:19G, 20G, 22GNeedle Length:1 inch, 3/4 inchTube Length:200mm (w/o NAC),180mm x 100mm(NAC) | Needle Gauge:19G, 20G, 22GNeedle Length:1 inch, 3/4 inchTube Length:200mm (w/o NAC),180mm x 100mm(NAC) | Same | |
| Priming volume(mL) | Standard bore : 1.3Micro bore(w/o NAC): 0.4Micro bore(with NAC): 0.9 | Standard bore : 1.3Micro bore(w/o NAC): 0.4Micro 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 StickProtector (ANSP) | ANSP*Minor modification to ANSP | ANSP | Different(butequivalent) |
| Injection site | needleless access connector(NAC) / none | needleless access connector(NAC) / none | Same | |
| Component &Material | See Table 2 | See Table 2 | Different(butequivalent) | |
| Sterilization | Ethylene Oxide Gas (ETO) | Ethylene Oxide Gas (ETO) | Same | |
| Shelf Life | 3 years | 3 years | Same |
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| 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.
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| 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 changedinto straw CAP, from T-CAP of predicate device(K123344). In order to make sure that thefunction of the needle cap has not changed,measurement of cap removal force is performedwith the new and old caps. |
| Method: | The removal force was measured when removingthe cap by hand from the product fixed on aforce gauge.Sample size: N= 30 for each cap. | |
| AcceptanceCriteria: | The removal resistance of straw cap is lowerthan T-cap.(In-house criteria) | |
| Result: | Conforms | |
| DiscussionandConclusion: | Cap removal force was lower with straw capcompared to T-CAP. Moreover, as per thetransportation test already performed there wasno cap detachment due to the transportation.As a conclusion, it was confirmed that there wasno change in the function of the needle cap dueto this modification. |
PERFC TESTI REMO
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| Simulated Use Testing(Sharps InjuryPrevention testing): | K-Shield Advantage Port Access Infusion Set includessharps injury prevention feature (Anti-needle StickProtector; ANSP). As ANSP of the device wasmodified, simulated use testing was conducted toevaluate the safety and effectiveness of its function.The test was conducted as per ISO 23908:2011 andFDA Guidance – Medical Device with Sharp InjuryPrevention Features. |
|---|---|
| For all of effective samples (n=599) evaluated, properactivation of ANSP were observed. This result exceedsthe pre-defined acceptance criteria. The resultconfirmed that the anti- needle stick function of themodified K-Shield Advantage PAIS works as safelyand effectively as the predicate device. | |
| CONCLUSIONS: | The K-Shield Advantage Port Access Infusion Set(PAIS) is substantially equivalent to the predicatedevice. Testing against established standards andguidelines for its intended use and results of the riskanalysis demonstrate that the proposed device issubstantially equivalent to the predicate device. |
§ 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.