K-Shield Advantage Port Access Infusion Set (PAIS)

K190233 · Kawasumi Laboratories, Inc. · FPA · May 2, 2019 · General Hospital

Device Facts

• Record ID: K190233
• Device Name: K-Shield Advantage Port Access Infusion Set (PAIS)
• Applicant: Kawasumi Laboratories, Inc.
• Product Code: FPA · General Hospital
• Decision Date: May 2, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to administer solutions to surgically implanted port.

Device Story

Safety port access infusion set; utilizes non-coring Huber needle to access surgically implanted ports; administers solutions. Features integral anti-needlestick protector (ANSP) to cover needle tip upon removal, preventing accidental needlestick injuries and bloodborne pathogen exposure. Used in hospital/healthcare settings by clinicians. Modifications from predicate include strengthened safety feature, improved gripping point for cannulation, and reduced needle cap bulkiness. Device is disposable, ethylene oxide sterilized, and includes tubing (micro or standard bore), clamp, female luer, and optional needleless access connector (NAC).

Clinical Evidence

No clinical data. Bench testing only. Performance verified via functional testing (tensile strength, leak tests, chemical tests per ISO 8536-4/ISO 7864) and simulated use testing for sharps injury prevention (n=599, 100% successful ANSP activation). Packaging and transportation testing (ISTA 2A, ISO 11607-1) confirmed integrity.

Technological Characteristics

Materials: Stainless steel needle, PVC hub/tubing (TOTM plasticized), PE needle cap, PP ANSP wing, epoxy glue. Energy: None (gravity feed). Connectivity: None. Sterilization: Ethylene Oxide (ETO). Form factor: Infusion set with Huber needle, tubing, and safety protector. Standards: ISO 8536-4, ISO 7864, ISO 11607-1, ISO 23908.

Indications for Use

Indicated for patients requiring administration of solutions to a surgically implanted port.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• K-Shield Advantage Port Access Infusion Set (K123344)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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.<br>Shinagawa Intercity Tower B<br>2-15-2, Konan,<br>Minato-ku, Tokyo, JAPAN 108-6109 |
| CONTACT PERSON: | Valerie Followell<br>Regulatory Affairs Consultant<br>Regulatory Compliance Associates®, Inc.<br>10411 Corporate Drive, Suite 102<br>Pleasant Prairie, Wisconsin 53158<br>Telephone: [phone]<br>Email: [e-mail] |
| DEVICE NAME: | Trade name: K-Shield Advantage Port<br>Access Infusion Set (PAIS)<br>Common name: Set, IV Fluid Transfer<br>set, administration,<br>intravascular<br>Classification:<br>Regulation<br>Number: 21 CFR 880.5440<br>Class: Product Class II<br>Code: FPA<br>Secondary<br>Product Code: PTI |
| PREDICATE DEVICE(S): | Previously cleared 510(k) for Kawasumi<br>Laboratories, Inc., K-Shield Advantage Port Access<br>Infusion Set |

| Predicate | Device | Indication | Clearance date | Company |
|-----------|----------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------|--------------------------------|
| 510(k) | Name | | | |
| K123344 | K-Shield Advantage<br>Port Access Infusion<br>Set (PAIS) | a safety port access device<br>used to administer solutions<br>to surgically implanted port. | 03/07/2013 | Kawasumi<br>Laboratories, Inc. |

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| DEVICE DESCRIPTION: | The K-Shield Advantage Port Access Infusion Set (PAIS)<br>is a safety port access device used to administer solutions<br>to a surgically implanted port. This device is designed<br>utilizing a non-coring Huber needle to access the implanted<br>port. The K-Shield Advantage PAIS has an integral safety<br>device intended to protect against accidental needle stick<br>injuries and infection caused by blood borne pathogens.<br>Upon removal from the port, the anti-needlestick protector<br>(ANSP) covers the needle tip protecting against accidental<br>needle stick injuries.<br>The devices are disposable ethylene oxide sterilized<br>medical devices which are constructed from non-coring<br>needle (Huber needle), wing, tubing (either micro bore or<br>standard bore), clamp, female conical fitting and locking<br>cap. The device has optional injection site (needle<br>injection, needleless access connector (NAC), or no<br>injection site) and anti-needle stick protector (ANSP). |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INDICATIONS FOR USE<br>STATEMENT: | The K-Shield Advantage Port Access Infusion Set (PAIS)<br>is a safety port access device used to administer solutions<br>to surgically implanted port. |
| TECHNOLOGICAL<br>CHARACTERISTICS: | The K-Shield Advantage Port Access Infusion Set (PAIS)<br>is substantially equivalent to the predicate device with<br>regard to technological characteristics, performance, and<br>intended use.<br><br>The proposed K-Shield Advantage Port Access Infusion<br>Set has minor enhancements to the original design of the<br>predicate device. These modifications include<br>strengthening the safety device feature, improving gripping<br>point for easy cannulation and reducing bulkiness of the<br>needle cap. The modifications do not affect the intended<br>use of the device or alter the fundamental scientific<br>technology of the device. |

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| | Features | Subject Device | Predicate Device | |
|---------------|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Regulatory | Device Name | K-Shield Advantage Port Access<br>Infusion Set (PAIS) | K-Shield Advantage Port Access<br>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<br>access device used to administer<br>solutions to surgically implanted<br>port. | This product is a safety port<br>access device used to administer<br>solutions to surgically implanted<br>port. | Same |
| | Packaging | Blister rigid tray with heat sealed<br>lid | Blister rigid tray with heat sealed<br>lid | Same |
| | Size | Needle Gauge:<br>19G, 20G, 22G<br>Needle Length:<br>1 inch, 3/4 inch<br>Tube Length:<br>200mm (w/o NAC),<br>180mm x 100mm(NAC) | Needle Gauge:<br>19G, 20G, 22G<br>Needle Length:<br>1 inch, 3/4 inch<br>Tube Length:<br>200mm (w/o NAC),<br>180mm x 100mm(NAC) | Same |
| | Priming volume<br>(mL) | Standard bore : 1.3<br>Micro bore(w/o NAC): 0.4<br>Micro bore(with NAC): 0.9 | Standard bore : 1.3<br>Micro bore(w/o NAC): 0.4<br>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<br>Protector (ANSP) | ANSP<br>*Minor modification to ANSP | ANSP | Different<br>(but<br>equivalent) |
| | Injection site | needleless access connector<br>(NAC) / none | needleless access connector<br>(NAC) / none | Same |
| | Component &<br>Material | See Table 2 | See Table 2 | Different<br>(but<br>equivalent) |
| | 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<br>(Subject device) | Material<br>(Predicate device K123344) |
|------------|----------------------|-----------------------------------|----------------------------------------|
| Needle | Y | Stainless Steel | Stainless Steel |
| Needle Cap | N | Polyethylene (PE) | Poly-propylene (PP) |
| ANSP Wing | Y<br>(*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<br>(PVC) | TOTM Poly-vinyl chloride<br>(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<br>- Seal strength<br>- 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<br>(ISO 8536-4) | ISO 8536-4:2010 (Amd 2013) | Pass |
| Test for tensile strength<br>(In house) | In house standard | Pass |
| Test for tensile Strength<br>(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<br>(modified K-Shield Advantage PAIS) is changed<br>into straw CAP, from T-CAP of predicate device<br>(K123344). In order to make sure that the<br>function of the needle cap has not changed,<br>measurement of cap removal force is performed<br>with the new and old caps. |
| | Method: | The removal force was measured when removing<br>the cap by hand from the product fixed on a<br>force gauge.<br>Sample size: N= 30 for each cap. |
| | Acceptance<br>Criteria: | The removal resistance of straw cap is lower<br>than T-cap.<br>(In-house criteria) |
| | Result: | Conforms |
| | Discussion<br>and<br>Conclusion: | Cap removal force was lower with straw cap<br>compared to T-CAP. Moreover, as per the<br>transportation test already performed there was<br>no cap detachment due to the transportation.<br>As a conclusion, it was confirmed that there was<br>no change in the function of the needle cap due<br>to this modification. |

# PERFC TESTI REMO

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| Simulated Use Testing<br>(Sharps Injury<br>Prevention testing): | K-Shield Advantage Port Access Infusion Set includes<br>sharps injury prevention feature (Anti-needle Stick<br>Protector; ANSP). As ANSP of the device was<br>modified, simulated use testing was conducted to<br>evaluate the safety and effectiveness of its function.<br>The test was conducted as per ISO 23908:2011 and<br>FDA Guidance – Medical Device with Sharp Injury<br>Prevention Features. |
|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | For all of effective samples (n=599) evaluated, proper<br>activation of ANSP were observed. This result exceeds<br>the pre-defined acceptance criteria. The result<br>confirmed that the anti- needle stick function of the<br>modified K-Shield Advantage PAIS works as safely<br>and effectively as the predicate device. |
| CONCLUSIONS: | The K-Shield Advantage Port Access Infusion Set<br>(PAIS) is substantially equivalent to the predicate<br>device. Testing against established standards and<br>guidelines for its intended use and results of the risk<br>analysis demonstrate that the proposed device is<br>substantially equivalent to the predicate device. |