The NIO+ Adult is intended to provide intraosseous (IO) access in the proximal tibia and the humeral head as an alternative to emergency IV access. Per urgent mecessity, humeral head IO access may be used when rapid fluid or pharmacological resuscitation is required. The device is intended for use in adult patients only.

Device Description

The NIO+ Adult (NIO+) is intended to be used with the same patient population and same age range. The NIO+ utilizes the very same technology and has the same operation method. The main difference is that the NIO+ provides a more physically robust version of the NIO Adult (NIO-A) which was selected to serve as the primary predicate device for this submission. The NIO+ was designed to better serve in tactical settings, such as battlefields, as the device and its package are more durable. It should be noted that the NIO-A is currently in use for all segments and settings that the NIO+ is targeted for. The additional robustness of the NIO+ is achieved by utilizing raw materials that have higher mechanical properties. The sterile single unit packaging robustness was increased, by using a rigid-blister and rigid plastic cover to protect the Tyvek paper. In addition, the maximal storage temperature was increased to 50°C versus room temperature, in order to assure that the device can function such extreme temperatures.

All NIO products are intended to be used by skilled, authorized medics, nurses, paramedics and doctors who are trained to use the device in military, emergency services and hospitals environments. The products are for single use and supplied sterile.

AI/ML Overview

The provided text is a 510(k) Summary for the NIO+ Adult device. It focuses on demonstrating substantial equivalence to a predicate device (NIO Adult) through non-clinical testing, rather than presenting a study that proves the device meets specific acceptance criteria in a clinical or AI-driven context.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" as it pertains to AI/algorithm performance (e.g., sample size for test/training set, expert ground truth, MRMC study, standalone performance, effect size) cannot be extracted from this document because it describes a medical device (a hypodermic needle) and its regulatory clearance process, not an AI or algorithm-driven diagnostic or treatment device.

The document details the device's technical characteristics, its intended use, and the non-clinical tests performed to ensure its safety and effectiveness. It explicitly states: "No clinical Study is included in this submission."

However, I can extract the non-clinical acceptance criteria and their proven performance based on the provided document.

Non-Clinical Acceptance Criteria and Reported Device Performance

The NIO+ Adult device is a hypodermic single lumen needle intended for intraosseous (IO) access. The approval relied on non-clinical performance testing to demonstrate substantial equivalence to a predicate device (NIO Adult, K142086). The acceptance criteria are implicit in the "Discussion of Technological Characteristics" and "Non-Clinical Performance Testing" sections, where the subject device's performance is compared to the predicate or to relevant standards.

1. Table of Acceptance Criteria and the Reported Device Performance (Non-Clinical Focus)

Acceptance Criteria (What was tested or demonstrated)	Reported Device Performance (How the device met the criteria)
Biocompatibility (no adverse effects on human tissue)	Complies with ISO 10993-1, 10993-4, 10993-5, 10993-10, 10993-11. The NIO+ uses the same needles and raw materials for body-contacting components as the predicate NIO-A, for which biocompatibility tests (sensitization, hemolysis, pyrogenicity, cytotoxicity, acute systemic toxicity, intracutaneous reactivity) were performed and apply to NIO+.
Trigger Mechanism Reliability and Penetration Depth Consistency	Tests conducted by WaisMed V&V team demonstrated compliance. (Specific quantitative results not provided in this summary, but implied to be within acceptable limits for substantial equivalence.) The device injects the needle to a penetration depth of 25±3mm into the bone marrow cavity.
Compressed Spring Force	Tests conducted by WaisMed V&V team demonstrated compliance. (Specific quantitative results not provided, but implied to be within acceptable limits.)
Trigger Safety Mechanisms Functionality (prevention of accidental activation)	The device has a rotational cap and requires simultaneous pressing against bone and pulling of the trigger mechanism; these safety features are equivalent to the predicate and demonstrated to function as intended.
Cannula Effective Length	Complies with ISO 9626 and ISO 7864. Needle length is 42mm.
Environmental and Transportation Testing (robustness to conditions)	Complies with ASTM D4332-14 and ASTM D4169. The NIO+ is designed to be more robust, serving in tactical settings and capable of use under extreme temperature conditions (50°C), an improvement over the predicate (room temperature).
Shelf Life	Complies with ISO 11607-1 and ASTM F1980-16. The NIO+ has a shelf life of 5 years at room temperature and 5 years at 50°C (an improvement over the predicate which was 5 years at room temperature).
Sterilization Validation (device sterility)	Complies with ISO 11137-1, ISO 11137-2, ISO 13004, ANSI AAMI ST72 (for bacterial endotoxins). Sterilization method is Gamma irradiation.
Conical Fitting Standard Compliance (Luer taper for connection)	Complies with ISO 594-1 and ISO 594-2. The cannula hub is a standard Luer hub.
Needle Dwelling Time	The device meets the requirement for a needle dwelling time of <24 Hours.
Material Equivalence (non-contacting and packaging) (Effect of material changes on safety/efficacy)	The change in materials for non-contacting components (body and spring) and sterile packaging (PETG injected sealed with Tyvek vs. PET-A sealed with Tyvek for predicate) were assessed by performance testing and "do not lead to new questions of safety and effectiveness." The new materials contribute to increased robustness for tactical settings and extreme conditions.
Substantial Equivalence to Predicate	All tests' results support WaisMed's labeling claims and demonstrate that the proposed device is as safe and as effective as the legally marketed predicate devices, despite differences in non-contact material, packaging material, and extended storage temperature conditions.

Regarding the AI/Algorithm-Specific Questions (as they are not applicable to this document):

Sample size used for the test set and the data provenance: Not applicable. No AI/algorithm test set was used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a physical medical instrument, not an AI aid for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable. No AI/algorithm training set was involved.
How the ground truth for the training set was established: Not applicable.

Summary

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July 22, 2021 WaisMed Ltd Shifra Hoch QA/RA Manager 10 Amal St. Afek Industrial Park Rosh Ha'Ayin, 4809234 Israel

Re: K211968

Trade/Device Name: NIO+ Adult Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: June 21, 2021 Received: June 24, 2021

Dear Shifra Hoch:

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 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 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) K211968

Device Name NIO+ Adult

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for WaisMed, a PerSys Medical Company. The word "WaisMed" is written in a combination of blue and red letters, with the "Wais" in blue and the "Med" in red. A registered trademark symbol is located to the right of the word "WaisMed". Below the company name, the text "A PerSys Medical Company" is written in a smaller font size.

K211968

Special 510(k) Summary

NIO+ Adult

510(k) Summarv:

1. Submitter Information

Name:	WaisMed Ltd
Address:	10 Amal St.Rosh Ha'Ayin, Israel
Contact Person:	Shifra Hoch
Phone:	+972-9-951-7444
E mail:	shifra@persysmedical.com

2. Date of Preparation

22 June 2021

3. Subject Device

Trade Name:	NIO+ Adult
Common Name:	Intraosseous infusion device
Regulation Number:	21 CFR 880.5570
Regulation Name:	Hypodermic Single Lumen Needle
Product Code:	FMI

4. Predicate Device

NIO Adult (WaisMed Ltd., K142086).

5. Device Description

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Image /page/4/Picture/0 description: The image shows the logo for WaisMed, a PerSys Medical Company. The word "WaisMed" is written in a combination of blue and red letters, with the "Wais" in blue and the "Med" in red. To the right of the word "WaisMed" is a circled R, indicating that the name is a registered trademark. Below the name is the text "A PerSys Medical Company".

materials that have higher mechanical properties. The sterile single unit packaging robustness was increased, by using a rigid-blister and rigid plastic cover to protect the Tyvek paper. In addition, the maximal storage temperature was increased to 50°C versus room temperature, in order to assure that the device can function such extreme temperatures.

Characteristics Subiect Modified Device Predicate Device WaisMed NIO+ WaisMed NIO-A K142086 Indications for The NIO+ Adult is intended to The NIO Adult is intended to Use provide intraosseous (IO) access in provide intraosseous access in the the proximal tibia and the humeral proximal tibia, as an alternative to head as an alternative to emergency IV access during emergencies. IV access. Per urgent medical The device is for use in adult necessity, humeral head IO access patients only. may be used when rapid fluid or The NIO is indicated for use in pharmacological resuscitation is providing intraosseous access as required. The device is intended for an alternative to IV access during use in adult patients only. emergencies. Humeral head access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible. The device is for use in adult patients only. Prescription only or Over the Prescription Prescription counter

6. Indications for Use Statement

Discussion of Differences in Indications for Use statement:

The NIO+ and the NIO-A have the same intended use, indications and clinical purpose. The only difference between both devices is the shelf life and storage conditions which are more suitable for military situations in extreme conditions.

Therefore, in terms of indications for use statement, the NIO+ is substantially equivalent to the selected predicate devices.

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Image /page/5/Picture/1 description: The image shows the logo for WaisMed, a PerSys Medical Company. The word "WaisMed" is written in a combination of blue and maroon colors, with the "Wais" part in blue and the "Med" part in maroon. To the right of the logo is a registered trademark symbol. Below the logo, the text "A PerSys Medical Company" is written in a smaller font size.

7. Summary of Technological Characteristics

Item	Subject Modified Device	Predicate Device	Comment
	WaisMed NIO+	WaisMed NIO-AK142086
TargetPopulation	Adults	Adults	Equivalent
AnatomicalSites	Proximal tibia and humeral head	Proximal tibia and humeral head	Equivalent
EnvironmentUsed	Hospital, clinic, emergency care.Additionally, may be used underextreme temperature conditions (50°c).	Hospital, clinic, emergency care,stored and used inroomtemperature.	Equivalent
Design	Automatic single-use device, includinga pre-loaded spring that releases theneedle to a predetermined IO depth.	Automatic single-use device,including a pre-loaded spring thatreleases the needleto a predeterminedIO depth.	Equivalent
Mechanism ofAction	The device resembles a syringe andwhen activated, a loaded spring isreleased and the device injects theneedle to a penetration depth of25±3mm into the bone marrow cavity.	The deviceresembles asyringe and whenactivated, a loadedspring is releasedand the deviceinjects the needleto a penetrationdepth of 25±3mminto the bonemarrow cavity.	Equivalent
SafetyMechanisms	1. Rotational cap to prevent accidentalactivation;2. Simultaneous pressing of deviceagainst the bone and pulling of thetrigger mechanism required toactivate the device.	1. Rotational capto preventaccidentalactivation;2. Simultaneouspressing ofdevice againstthe bone and	Equivalent
Item	Subject Modified Device	Predicate Device	Comment
	WaisMed NIO+	WaisMed NIO-A
		K142086
		pulling of thetriggermechanismrequired toactivate thedevice.
Insertion depth	Proximal tibia/humeral head: 2.5(cm)	Proximaltibia/humeralhead: 2.5(cm)	Equivalent
Insertion SiteIdentification	Proximal tibia: Approximately 1 inchor 2 cm medially and 1/2 inch or 1 cmproximally to the Tibial tuberosity.Humeral head: greater tubercle next tothe head of the humerus.	Proximal tibia:Approximately 1inch or 2 cmmedially and 1/2inch or 1 cmproximally to theTibial tuberosity.Humeral head:greater tuberclenext to the headof the humerus.	Equivalent
Materials	1. Stainless steel (trocar and cannulaneedle)2. Brass nickel-plated3. Plastic parts: Polycarbonate4. Body: Ultem5. Spring: Stainless Steel	1. Stainless steel(trocar andcannulaneedle)2. Brass nickel-plated3. Plastic partsnot includingBody:Polycarbonate4. Body:Polycarbonat5. Spring: Musicwire	Difference inmaterials.This change doesnot lead to newquestions of safetyand effectiveness.
Biocompatibility	Biocompatible. Complies with ISO10993-1	Biocompatible.Complies withISO 10993-1	Equivalent
Item	Subject ModifiedDevice	Predicate Device	Comment
	WaisMed NIO+	WaisMed NIO-AK142086
Needle dwellingtime	<24 Hours	<24 Hours	Equivalent
Hub Interface	The cannula hub is a standard hubLuerappropriate for connecting to anystandard infusion system.	The cannula hubis a standard hubLuer appropriatefor connecting toany standardinfusion system.	Equivalent
Needle length	42mm	42mm	Equivalent
Needle gauge	15G	15G	Equivalent
Single use	Single use	Single use	Equivalent
Sterilization	Sterile	Sterile	Equivalent
Sterilizationmethod	Gamma irradiation	Gammairradiation	Equivalent
SterilePackaging	PETG injected sealed with Tyvek	PET-A sealedwith Tyvek	Difference inmaterials.This change doesnot lead to newquestions of safetyand effectiveness.
StorageConditions	5 years at room temperature5 years at 50°C	5 years atroomtemperature	Difference instorageconditions.This change doesnot lead to newquestions of safetyand effectiveness.

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Image /page/6/Picture/1 description: The image shows the logo for WaisMed, a PerSys Medical Company. The word "WaisMed" is in a stylized font, with "Wais" in blue and "Med" in maroon. A registered trademark symbol is next to the word "Med". Below the company name is the text "A PerSys Medical Company".

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Discussion of Technological Characteristics

The following differences do not raise different question of safety and effectiveness.

The change in raw materials of the non-contacting components (body and spring) and of the packaging, contributes to the robustness of the NIO+ device in comparison to the NIO-A, which enables its use under tactical settings, especially for extreme conditions and temperatures, as supported by the additional storage conditions of 5 years at 50°C. These differences were assessed by performance testing, and there were no new questions of safety or effectiveness.

8. Non-Clinical Performance Testing

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Image /page/8/Picture/1 description: The image shows the logo for WaisMed, a PerSys Medical Company. The word "WaisMed" is in a stylized font, with "Wais" in blue and "Med" in red. A registered trademark symbol is next to the word "Med". Below the company name is the text "A PerSys Medical Company".

Body contact materials were evaluated for biocompatibility in accordance with FDA's Guidance for Use of ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", dated June 16, 2016 and ISO 10993 international standards series as detailed below.

The NIO-A and NIO+ are being manufactured using the same needles and the same raw materials for body contacting components. Therefore, no additional tests were necessary to evaluate the safety of the NIO+. Biocompatibility tests that were performed for the NIO-A, and apply for the NIO+ included, sensitization, hemolysis, pyrogenicity, cytotoxicity, acute system toxicity and intracutaneous reactivity.

The biocompatibility tests were conducted to verify that the proposed device will not adversely affect human tissue based on the following standards:

. ISO 10993-1:2018 – Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.
ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of ● tests for interactions with blood.
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in ● vitro cytotoxicity.
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for . irritation and skin sensitization.
ISO 10993-11:2006 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.

Other non-clinical tests were conducted to verify that the proposed device met all design specifications and is Substantially Equivalent (SE) to the predicates. The tests are as follows. Tests identified under subsections 'a', 'b', 'c' below are based on WaisMed V&V tests plan.

Tests identified under subsections 'd', 'e', 'f, 'g', 'h' are in compliance with applicable standards as follows:

a) Reliability testing of trigger mechanism and penetration depth;
b) Compressed spring force;
Trigger safety mechanisms; c)
d) Cannula effective length, per ISO 9626 and ISO 7864;
e) Environmental and transportation testing, per ASTM D4332-14 and ASTM D4169;
Shelf life, per ISO 11607-1 and ASTM F1980-16; f)
Sterilization validation, per ISO 11137-1, ISO 11137-2, ISO 13004, ANSI AAMI g) ST72;
h) Conical fitting, per ISO 594-1 and ISO 594-2.

The test results demonstrated that the proposed device complies with the following standards:

ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and .

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Image /page/9/Picture/1 description: The image shows the logo for WaisMed, a PerSys Medical Company. The word "WaisMed" is written in a combination of blue and red colors, with the "Wais" part in blue and the "Med" part in red. The registered trademark symbol is next to the word "Med". Below the company name is the text "A PerSys Medical Company".

certain other medical equipment - Part 1: General requirements.

ISO 594-2:1998 - Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings.
ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: . Requirements for development, validation and routine control of a sterilization process for medical devices.
ISO 11137-2:2013 Sterilization of Health Care Products Radiation Part 2: ● Establishing the Sterilization Dose.
ISO 13004:2013 Sterilization of health care products Radiation Substantiation ● of selected sterilization dose: Method VDmax SD.
ANSI AAMI ST72:2011/(R)2016 Bacterial endotoxins –Test methods, routine . monitoring, and alternatives to batch testing.
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier . Systems for Medical Devices.
ASTM D4332-14 - Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
ASTM D4169-16 Standard Practice for Performance Testing of Shipping ● Containers and Systems
. ISO 11607-1:2016 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ISO 7153-1:1999 Surgical instruments Metallic materials Part 1: Stainless . steel.
ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical ● devices - Requirements and test methods.
ISO 7864:2016 - Sterile hypodermic needles for single use - Requirements and test methods.

All tests' results support WaisMed's labeling claims in order to establish substantial equivalency.

9. Clinical Test Conclusion

No clinical Study is included in this submission.

10. Substantially Equivalent (SE) Conclusion

The evaluation of the subject device performance demonstrates that it is as safe and as effective as the legally marketed predicate devices.

Regulation Number and Section

§ 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).