(87 days)
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip syringe and injection devices for general purpose fluid injection/aspiration.
The Sterile Hypodermic Needles for Single Use is composed of a needle hub, protective cover, needle tube and jointing, connected with a luer lock or luer slip syringe and injection devices for general purpose fluid injection. The Sterile Hypodermic Needles for Single Use is for single use only. After opening the inner packaging and taking out the product, tighten the needle to the syringe and remove the protective cover, extract the drug liquid, exhaust the air and then inject. It is provided sterile. The sterilization method is EO sterilization and the sterilization assurance level is 10-6.
This document outlines the acceptance criteria and supporting study details for a Sterile Hypodermic Needle for Single Use (K231720) according to its 510(k) summary. This is not an AI/ML-based device, so many of the requested fields (especially those related to AI algorithm performance, human reader studies, and ground truth establishment for AI training/test sets) are not applicable.
The "device" in question is a physical medical device (hypodermic needles), not a software or AI-driven system. Therefore, the acceptance criteria and study descriptions are focused on physical and biological performance, rather than algorithm performance.
Acceptance Criteria and Device Performance for Sterile Hypodermic Needles for Single Use (K231720)
The substantial equivalence determination for this device is based on its compliance with established international and national standards for medical devices, rather than a comparative effectiveness study involving human readers or AI.
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|---|
| I. Biocompatibility | ||
| Cytotoxicity | ISO 10993-5:2009 | All evaluation acceptance criteria were met. |
| Skin Sensitization | ISO 10993-10:2010 | All evaluation acceptance criteria were met. |
| Hemolysis | ISO 10993-4:2017 | All evaluation acceptance criteria were met. |
| Intracutaneous Reactivity | ISO 10993-10:2010 | All evaluation acceptance criteria were met. |
| Acute Systemic Toxicity | ISO 10993-11:2017 | All evaluation acceptance criteria were met. |
| Pyrogenicity | ISO 10993-11:2017 (for testing); Device non-pyrogenic (for general claim) | All evaluation acceptance criteria were met; Non-pyrogenic. |
| Particulate Matter | USP <788> Particulate Matter in Injections | Met USP acceptance criteria. |
| II. Sterilization & Shelf Life | ||
| Sterilization Validation | ISO 11135:2014 (EO Sterilization) | Sterilization method validated to ISO11135. |
| EO Residue | ISO 10993-7:2008 | Compliant with ISO 10993-7:2008. |
| ECH Residue | ISO 10993-7:2008 | Compliant with ISO 10993-7:2008. |
| Bacterial Endotoxin | USP42-NF37<85> | Compliant with USP42-NF37<85>. |
| Shelf Life (Stability) | Ageing test (method not specified but implies meeting performance over time) | Five (5) years. |
| Sterile Barrier Packaging | ASTM F88/F88M-15 (Seal Strength) | Compliant. |
| ASTM F1929-15 (Dye Penetration) | Compliant. | |
| ASTMF1140/F1140M-13 (Creep/Burst Testing) | Compliant. | |
| ASTM F2096-11 (Gross Leakage) | Compliant. | |
| III. Performance Testing | ||
| Cleanliness | ISO 7864:2016 Clause 4.3; ISO 9626:2016 Clause 5.3 | Complied (implied by "all evaluation acceptance criteria were met" for biocompatibility tests which can be affected by cleanliness, and by general statement of compliance with these standards). |
| Limits for acidity or alkalinity | ISO 7864:2016 Clause 4.4; ISO 9626:2016 Clause 5.4 | Complied. |
| Limits for extractable metals | ISO 7864:2016 Clause 4.5 | Complied. |
| Tubular needle designation | ISO 7864:2016 Clause 4.6 | Complied. |
| Color coding | ISO 7864:2016 Clause 4.7; ISO 6009 | Complied (Color-coded per ISO 6009). |
| Needle hub | ISO 7864:2016 Clause 4.8; ISO 80369-7 | Complied. |
| Needle cap | ISO 7864:2016 Clause 4.9 | Complied. |
| Needle tube (Tolerance on length, Freedom from defects, Lubricant) | ISO 7864:2016 Clause 4.10 | Complied. |
| Needle Point | ISO 7864:2016 Clause 4.11 | Complied. |
| Bond between Tube and Hub | ISO 7864:2016 Clause 4.12 | Complied. |
| Patency of Lumen | ISO 7864:2016 Clause 4.13 | Complied. |
| Surface finish & visual appearance | ISO 9626:2016 Clause 5.2 | Complied. |
| Size designation | ISO 9626:2016 Clause 5.5 | Complied. |
| Dimensions | ISO 9626:2016 Clause 5.6 | Complied. |
| Stiffness | ISO 9626:2016 Clause 5.8 | Complied. |
| Resistance to breakage | ISO 9626:2016 Clause 5.9 | Complied. |
| Resistance to corrosion | ISO 9626:2016 Clause 5.10 | Complied. |
| Dimensional requirements for luer connectors | ISO 80369-7:2021 Clause 5 | Complied. |
| Fluid leakage (Positive pressure liquid leakage) | ISO 80369-7:2021 Clause 6.1.3 | Complied. |
| Sub-atmospheric pressure air leakage | ISO 80369-7:2021 Clause 6.2 | Complied. |
| Stress cracking | ISO 80369-7:2021 Clause 6.3 | Complied. |
| Resistance to separation from axial load | ISO 80369-7:2021 Clause 6.4 | Complied. |
| Resistance to separation from unscrewing | ISO 80369-7:2021 Clause 6.5 | Complied. |
| Resistance to overriding | ISO 80369-7:2021 Clause 6.6 | Complied. |
| IV. Labeling | 21 CFR Part 801 | Met the requirements of 21 CFR Part 801. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test. Testing of physical medical devices typically involves testing a statistically significant sample size from a production lot to demonstrate compliance with standards. The data provenance is implied to be from laboratory testing performed on the manufacturer's device, likely in China (where the manufacturer is located). The testing is prospective for the purpose of demonstrating compliance for this specific device model.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is a physical medical device (hypodermic needle), not an AI/ML diagnostic or image analysis system. Ground truth is established through validated laboratory test methods and established international/national standards, not through expert consensus in the medical imaging context.
4. Adjudication Method for the Test Set
This is not applicable as the ground truth is established through objective laboratory testing against defined standards (e.g., ISO, ASTM, USP), not through the adjudication of medical opinion.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML-driven diagnostic aids that assist human readers in interpreting medical images. This device is a sterile hypodermic needle, a physical disposable medical tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance evaluation in the context of an AI algorithm was not done. This is not an algorithmic device.
7. The Type of Ground Truth Used
The "ground truth" for this physical device is defined by the acceptance criteria specified in the referenced international standards (e.g., ISO 10993, ISO 7864, ISO 9626, ISO 80369, ASTM, USP). These standards define the physical, chemical, and biological properties a device must meet to be considered safe and effective for its intended use. Testing protocols outlined within these standards serve as the objective 'ground truth' against which the device's performance is measured. Compliance is determined by the device meeting all the specified numerical and qualitative requirements of these standards.
8. The Sample Size for the Training Set
This information is not applicable as there is no "training set" in the context of a physical medical device. The manufacturing process is controlled by Good Manufacturing Practices (GMP) and validated testing, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" involved in the development or evaluation of this 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 8, 2023
Wepon Medical Technology Co., Ltd. % Esther Zhang Official Correspondent Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2, Wanyuan Rd. Minhang District Shanghai, Shanghai 201102 China
Re: K231720
Trade/Device Name: Sterile Hypodermic Needles for Single Use Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: June 8, 2023 Received: June 13, 2023
Dear Esther Zhang:
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
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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 medical devices and radiation-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,
Alan Sthe
CAPT Alan Stevens 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
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Indications for Use
510(k) Number (if known) K231720
Device Name Sterile Hypodermic Needles for Single Use
Indications for Use (Describe)
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer slip syringe and injection devices for general purpose fluid injection/aspiration.
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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Section 5 510(k) summary
l Submitter
Device submitter: Wepon Medical Technology CO., LTD. Floor 4, Building A, No. 58, Jinhu Road, Chengdong Street, Wenling Zhejiang, CN 317500
Contract manufacturer: Zhejiang Kangkang Medical-Devices CO., Ltd. Longwang Industrial District, Chumen Town, Yuhuan, Zhejiang, 317605, China Registration number: 3015042030
Contact person: Di Zhao Deputy General Manager Phone: 928-5922380 Email: dizhao@wepon-ppe.com
II Correspondent
Shanghai Ling Fu Technology Co., Ltd. 4F No. 585-2, Wanyuan Rd. Minhang District, Shanghai, P.R.China Contact: Esther ZHANG Email: Esther.zhang@llins-tech.com
III Device
Trade Name of Device: Sterile Hypodermic Needles for Single Use Common Name: Hypodermic Single Lumen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product code: FMI Review Panel: General Hospital
IV Predicate Devices
| Trade name: | Sterile Hypodermic Needles for Single Use (used as the predicate device); |
|---|---|
| Common name: | Hypodermic single lumen needle |
| Classification: | Class II, 21 CFR 880.5570 |
| Product Code: | FMI |
| Premarket Notification: | K180417 |
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Manufacturer:
V Device description
The Sterile Hypodermic Needles for Single Use is composed of a needle hub, protective cover, needle tube and jointing, connected with a luer lock or luer slip syringe and injection devices for general purpose fluid injection. The Sterile Hypodermic Needles for Single Use is for single use only. After opening the inner packaging and taking out the product, tighten the needle to the syringe and remove the protective cover, extract the drug liquid, exhaust the air and then inject. It is provided sterile. The sterilization method is EO sterilization and the sterilization assurance level is 10-6.
| GaugeLength | 30G | 27G | 26G | 25G | 24G | 23G | 22G | 21G | 20G | 19G | 18G |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1/2" | ● | ● | ● | ||||||||
| 5/8" | ● | ● | ● | ||||||||
| 1" | ● | ● | ● | ● | ● | ● | ● | ● | |||
| 1 1/4" | ● | ● | ● | ● | ● | ● | |||||
| 1 1/2" | ● | ● | ● | ● | ● | ● |
Table 1 specification of proposed device
VI Indications for use
The Sterile Hypodermic Needles for Single Use are intended to be used with a luer lock or luer slip syringe and injection devices for general purpose fluid injection/aspiration.
VII Comparison of technological characteristics with the predicate devices
The Sterile Hypodermic Needles for Single Use have intended use, technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Sterile Hypodermic Needles for Single Use and predicate devices do not alter suitability of the proposed device for its intended use.
| Devicefeature | Subject Device | Predicate DeviceK180417 | Comments |
|---|---|---|---|
| Indications foruse | The Sterile HypodermicNeedles for Single Useare intended to be usedwith a luer lock or luer slipsyringe and injectiondevices for generalpurpose fluidinjection/aspiration. | The Sterile HypodermicNeedles forSingle Use are intended tobe used with a luer slip orluer slip syringe andinjection devices forgeneral purpose fluidinjection/aspiration. | Same |
| Product code | FMI | FMI | Same |
| Regulation | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Devicefeature | Subject Device | Predicate DeviceK180417 | Comments |
| number | |||
| Class | II | II | Same |
| Principle ofoperation | For manual use only | For manual use only | Same |
| Intended user | Medical professionals andtrained care givers | Medical professionals andtrained care givers | Same |
| Environmentof use | Hospitals and clinics | Hospitals and clinics | Same |
| Needle gauge | 30G, 27G, 26G, 25G,24G, 23G, 22G, 21G,20G, 19G, 18G | 14G, 15G, 16G, 17G,18G, 19G, 20G, 21G,22G, 23G, 24G, 25G,26G, 27G, 29G, 30G | Difference |
| Length | 1/2", 5/8", 1", 1¼", 1½" | 6-60mm | |
| Type of wall | normal wall or thin wall | not provide | |
| blade angle | short bevel or long bevel | not provide | |
| Needle hub | Needle hubPolypropylene | Needle hubPolypropyle ne | Same |
| main structureand materials | Needle tubeStainless steel | NeedleStainless steel | |
| protectivecoverPolypropylene | protectivecapPolypropyle ne | ||
| Needle hub | Color-coded per ISO 6009 | Color-coded per ISO 6009 | Same |
| Single use | Yes | Yes | Same |
| Performancespecifications | Complies with ISO 7864;ISO 9626; ISO 80369-7 | Complies with ISO 7864;ISO 9626; ISO 80369-7 | Same |
| Sterilization | EO | EO | Same |
| SAL | 10-6 | 10-6 | Same |
| Pyrogen | Non-pyrogenic | Non-pyrogenic | Same |
| Biocompatibility | Thebiocompatibilityevaluation for the subjectdevice was conducted inaccordance with theInternational Standard ISO10993-1 "BiologicalEvaluation of MedicalDevices - Part 1:Evaluation and TestingWithin a Risk | Comply with ISO 10993.The test is as follows:The devices meetbiocompatibility endpointsfor cytotoxicity, irritation,sensitization, systemictoxicity, andhemolysis material-mediatedpyrogens | Same |
| Devicefeature | Subject Device | Predicate DeviceK180417 | Comments |
| Management Process," asrecognized by FDA andthe "Use of InternationalStandard ISO 10993-1"Biological evaluation ofmedical devices- Part 1:Evaluation and testingwithin a risk managementprocess", June 16, 2016.The syringe of testingincluded the followingtests:Cytotoxicity;Skin sensitization;Hemolysis;Intracutaneous reactivity;Acute systemic toxicity;Pyrogenicity.The evaluation of theabove testing items meetsthe requirements | |||
| Labeling | Meet the requirements of21 CFR Part 801 | Meet the requirements of21 CFR Part 801 |
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Different 1
The needle gauge and length of subject devices are different from the predicate device, and the type of wall and needle bevel are unknown. The subject device specifications are within the range of the predicate device. This difference does not affect intended use and does not raise different questions of safety and effectiveness.
VIII Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Sterile Hypodermic Needles for Single Use were evaluated in accordance with ISO 10993-1:2018 for the body contact category of "External
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communication device - Blood path indirect" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended:
| Cytotoxicity | ISO 10993-5: 2009 |
|---|---|
| Skin sensitization | ISO 10993-10: 2010 |
| Hemolysis | ISO 10993-4: 2017 |
| Intracutaneous reactivity | ISO 10993-10: 2010 |
| Acute systemic toxicity | ISO 10993-11: 2017 |
| Pyrogenicity | ISO 10993-11: 2017 |
All evaluation acceptance criteria were met.
Particulate matter testing was conducted in accordance with USP <788> Particulate Matter in Injections and met the USP acceptance criteria.
Sterilization and shelf life testing
The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Sterile Hypodermic Needles for Single Use is determined based on stability study which includes ageing test. The shelf-life of the Sterile Hypodermic Needles for Single Use is five (5) years.
| Sterilization Evaluation | ISO11135: 2014 |
|---|---|
| EO residue | ISO 10993-7:2008 |
| ECH residue | ISO 10993-7:2008 |
| Bacterial Endotoxin testing | USP42-NF37<85> |
| Sterile barrier packaging testing &Shelf Life Evaluation | Seal Strength ASTM F88/F88M-15Dye Penetration ASTM F1929-15Creep/Burst TestingASTMF1140/F1140M-13Gross Leakage ASTM F2096-11 |
Antibacterial Testing DIN 58953-6:2010
Performance testing
Freedom from defects, Lubricant)
Performance testing is performed according to the following standards:
| ➤ | ISO 7864: 2016 | |
|---|---|---|
| Cleanliness | Clause 4.3 of ISO 7864: 2016 | |
| Limits for acidity or alkalinity | Clause 4.4 of ISO 7864: 2016 | |
| Limits for extractable metals | Clause 4.5 of ISO 7864: 2016 | |
| Tubular needle designation | Clause 4.6 of ISO 7864: 2016 | |
| Colour coding | Clause 4.7 of ISO 7864: 2016 | |
| Needle hub | Clause 4.8 of ISO 7864: 2016, ISO | |
| 80369-7 and ISO 6009 | ||
| Needle cap | Clause 4.9 of ISO 7864: 2016 | |
| Needle tube (Tolerance on length, | Clause 4.10 of ISO 7864: 2016 |
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| Needle Point | Clause 4.11 of ISO 7864: 2016 | |
|---|---|---|
| Bond between Tube and Hub | Clause 4.12 of ISO 7864: 2016 | |
| Patency of Lumen | Clause 4.13 of ISO 7864: 2016 | |
| > | ISO 9626:2016 | |
| Surface finish and visual appearance | Clause 5.2 of ISO 9626:2016 | |
| Cleanliness | Clause 5.3 of ISO 9626:2016 | |
| Limits for acidity and alkalinity | Clause 5.4 of ISO 9626:2016 | |
| Size designation | Clause 5.5 of ISO 9626:2016 | |
| Dimensions | Clause 5.6 of ISO 9626:2016 | |
| Stiffness | Clause 5.8 of ISO 9626:2016 | |
| Resistance to breakage | Clause 5.9 of ISO 9626:2016 | |
| Resistance to corrosion | Clause 5.10 of ISO 9626:2016 | |
| > | ISO 80369-7:2016 | |
| Dimensional requirements for luerconnectors. | Clause 5 of ISO 80369-7: 2021 | |
| Fluid leakage (Positive pressure liquidleakage) | Clause 6.1.3 of ISO 80369-7: 2021 | |
| Sub-atmospheric pressure air leakage | Clause 6.2 of ISO 80369-7: 2021 | |
| Stress cracking | Clause 6.3 of ISO 80369-7: 2021 | |
| Resistance to separation from axial load | Clause 6.4 of ISO 80369-7: 2021 | |
| Resistance to separation from | Clause 6.5 of ISO 80369-7: 2021 | |
| unscrewing | ||
| Resistance to overriding | Clause 6.6 of ISO 80369-7: 2021 |
IX Conclusion
The Sterile Hypodermic Needles for Single Use are substantially equivalent to its predicate device. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).