The NIO-I is an Intraosseous device intended to provide vascular access in the proximal tibia of infants as an alternative to emergency IV access. It is indicated for use in infants between gestational age of 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age.

Device Description

The NIO-I is a manual intraosseous device. It includes a lightweight ergonomic handle for easy and fast manual insertion of the needle into the medullary cavity. The device is designed specifically for infants between 0 and 3 years of age. The NIO-I provides haptic feedback via the stepped-needle design that helps preventing over-penetration into the distal cortex. After insertion of the needle, the user disconnects the handle and pulls out the trocar leaving the cannula inside the medullary cavity. Through the cannula, the caregiver can infuse fluids and drugs that will reach the vascular system.

AI/ML Overview

The provided text is a 510(k) premarket notification for the NIO-I intraosseous device. It does not contain a study comparing the device to acceptance criteria but rather a comparison to predicate devices and a summary of non-clinical performance testing. Therefore, I cannot fully answer your request.

However, I can extract the information related to the non-clinical performance testing which serves as evidence for the device's acceptable performance against established standards.

1. Table of Acceptance Criteria (from Standards) and Reported Device Performance:

The document lists several non-clinical tests and the standards they comply with. These standards implicitly contain the acceptance criteria. The reported device performance is that it successfully complied with these standards.

Test Category	Specific Test / Standard	Reported Device Performance
Biocompatibility	ISO 10993-1: Evaluation and testing within a risk management process	Complies with ISO 10993-1 and related standards (10993-4, 10993-5, 10993-10, 10993-11)
	Sensitization, Hemolysis, Material-mediated pyrogenicity, Cytotoxicity, Acute systemic toxicity, Intracutaneous reactivity	Passed successfully all applicable biocompatibility tests.
Physical/Mechanical	Force required for needle cover removal	(Implicitly passed design specifications)
	Visual inspection for corrosion, per ISO 9626	Complies with ISO 9626
	Force required for needle insertion	(Implicitly passed design specifications)
	Minimal force for insertion of the needle	(Implicitly passed design specifications)
	Force for detachment of the needle housing from the needle gripper	(Implicitly passed design specifications)
	Maximum force for trocar removal after insertion to the platform	(Implicitly passed design specifications)
	Cannula effective length, per ISO 9626 and ISO 7864	Complies with ISO 9626 and ISO 7864
	Maximum force for cannula removal after insertion	(Implicitly passed design specifications)
Usability	Usability study, per IEC 62366-1	Complies with IEC 62366-1
Shelf Life/Packaging	Shelf life, per ISO 11607-1 and ASTM F1980-16	Complies with ISO 11607-1 and ASTM F1980-16
Sterilization	Sterilization validation, per ISO 11137-1, ISO 11137-2, ISO 13004, ANSI AAMI ST72	Complies with ISO 11137-1, ISO 11137-2, ISO 13004, ANSI AAMI ST72
	Limits for acidity or alkalinity, per ISO 7864	Complies with ISO 7864
Connection (Luer)	Conical fitting, per ISO 594-1 and ISO 594-2	Complies with ISO 594-1 and ISO 594-2

2. Sample sized used for the test set and the data provenance:

The document does not explicitly state the sample sizes for the individual non-clinical tests. It refers to these as "Waismed V&V tests plan" and compliance with international standards. Data provenance is not described beyond stating "non-clinical tests were conducted".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable as the document describes non-clinical performance testing and compliance with standards, not a study utilizing expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable as the document describes non-clinical performance testing and compliance with standards.

5. 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:

This information is not applicable. The device is a physical intraosseous needle and does not involve AI or human "readers".

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable. The device is a physical intraosseous needle.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria established within the international standards (e.g., ISO 10993, ISO 9626, IEC 62366, etc.).

8. The sample size for the training set:

This information is not applicable as the document describes non-clinical performance testing of a physical device, not an algorithm 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 this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 7, 2019

WaisMed Ltd % Tali Hazan Consultant Talmed Ltd Ramot Naftali, 1383000 Il

Re: K190538

Trade/Device Name: NIO-I Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: August 27, 2019 Received: September 5, 2019

Dear Tali Hazan:

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

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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 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,

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) K190538

Device Name NIO-I

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 colors, with "Wais" in blue and "Med" in red. Below the company name, the text "A PerSys Medical Company" is written in a smaller, gray font. There is a gray swoosh design element on the bottom left of the logo.

510(k)Summary: K190538

1. Submitter Information

WaisMed Ltd 10 Amal St. Rosh Haayin, Israel Phone: +972-72-2234585 Fax: +972-9-9517666 E mail: maya@persysmedical.com

Contact person name: Ms. Tali Hazan - RA Consultant Phone: +972-(0)50-5292-304 Fax: +972-(0)722448981 Email: tali.hazan@talmed.co.il

2. Date of Preparation

4th October, 2019

3. Identification of Predicate

a. Primary Predicate

VidaCare Corporation's PD-IO, Disposable Intraosseous Infusion Needle and Handle cleared under 510(k) number K043490 on February 18, 2005.

b. Secondary Predicate

VidaCare Corporation's EZ-MIO Manual Driver cleared under 510(k) number K052195 on November 2, 2005.

4. Identification of Subject Device

a. Regulatory Information Regulation Name: Hypodermic single lumen needle Regulation Number: 880.5570 Product Code: FMI Common Name: Needle, Hypodermic, Single Lumen Proprietary/Trade name: NIO-I

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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 colors. The first part, "Wais," is in blue, while the second part, "Med," is in red. Below the name, in smaller, gray font, is the text "A PerSys Medical Company."

5. Device Description

Characteristics	Subject DeviceWaismed NIO-IK190538	Primary PredicateVidaCare Corp.K043490	Secondary PredicateEZ-MIO IntraosseousInfusion SystemK052195
Indications for Use	The NIO-I is anintraosseous deviceintended to providevascular access in theproximal tibia ofinfants as analternative toemergency IV access.It is indicated for usein infants betweengestational age of 36weeks and weight ofat least 5 pounds (2.3Kg) and up to 3 yearsof age.	The PD-IODisposableIntraosseous InfusionNeedle and Handleprovides intraosseousaccess in the proximaltibia, as an alternativeto IV access duringemergencies. Thedevice is for use inpediatric patients.	For pediatric use: ThePD-IO™ infusionsystem providesintraosseous access inproximal tibia, as analternative to IV accessduring emergencies topediatric patients, frombirth to 21 years of age(approximate weightrange: 3 kg - 39 kg).For adult use: The EZ-IOTM Infusion Systemprovides intraosseousaccess in the proximaltibia, as an alternative toIV access duringemergencies to adultpatients (22 years of ageor older, > 40 kg)*Note: the adult usepart of the indicationsfor use is not included inthis submission.

6. Indications for Use Statement

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Image /page/5/Picture/0 description: The image contains the logo for WaisMed, a PerSys Medical Company. The word "WaisMed" is written in a combination of blue and red colors, with "Wais" in blue and "Med" in red. Below the company name, the text "A PerSys Medical Company" is written in a smaller, gray font. The logo is simple and professional, likely representing a medical or healthcare-related business.

Characteristics	Subject DeviceWaismed NIO-IK190538	Primary PredicateVidaCare Corp.K043490	Secondary PredicateEZ-MIO IntraosseousInfusion SystemK052195
Prescription Onlyor Over thecounter	Prescription	Prescription	Prescription

Discussion of Differences in Indications for Use statement:

The NIO-I and the EZ-MIO have the same intended use, indications and clinical purpose. Slight differences in the age range of each device dose not raise new questions of safety and effectiveness since the NIO-I is intended to narrower age population and.

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

7. Summary of Technological Characteristics

Item	Subject DeviceWaismed NIO-IK190538	PrimaryPredicateVidaCare Corp.K043490	SecondaryPredicateEZ-MIOIntraosseousInfusion SystemK052195	Comment
TargetPopulation	Emergency Carefor infantpatients (0-3years of age)	Emergency Carefor pediatricpatients (0-21years of age)	Emergency Carefor pediatric andadult patients	See comment #1
AnatomicalSites	Proximal Tibia	Proximal Tibia	Proximal Tibia	Same
EnvironmentUsed	Hospital, Clinic,Emergency Care	Hospital, Clinic,Emergency Care	Hospital, Clinic,Emergency Care	Same
Design	Consists oftrocar needle,stylet and	Consists of trocarneedle, stylet andcatheter, needle	Consists of apentagon shaftpermanently	Same
Item	Subject DeviceWaismed NIO-IK190538	PrimaryPredicateVidaCare Corp.K043490	SecondaryPredicateEZ-MIOIntraosseousInfusion SystemK052195	Comment
	catheter, needlecover and ahandle.	cover and ahandle.	attached to ahandle andconnected to thePD-IO (forpediatrics)
Mechanism ofAction	Manually inthree stages:(1) The NIO-Ineedle ismanuallyinserted throughthe cortex of thebone untilchange isresistance is felt,indicating theneedle penetratedthe bone marrowcavity.(2) The insertionhandle is thendisconnectedfrom the needleand, (3) thetrocar is removedby pulling itupwards.	Manually in threestages:(1) The PD-IOneedle ismanually insertedthrough thecortex of thebone to a desireddepth within thebone marrow. (2)The insertionhandle withtrocar is thenseparated fromthe catheter hubby turning thehandle counterclockwise andthen, (3) beingremoved, leavingthe a standardluer lock cathetersecurely seated inthe bone.	Manual needleinsertion usingstylet andcatheter into thebone cortex to adesired depthwithin the bonemarrow.After insertion ofthe needle set themanual driver isdetached fromthe needle setleaving the styletand cannulafirmly seated inthe bone. Thestylet is thenseparated andremoved fromthe catheter byturning the stylethub counterclockwise,leaving astandard luerlock catheter	Same
Item	Subject DeviceWaismed NIO-IK190538	PrimaryPredicateVidaCare Corp.K043490	SecondaryPredicateEZ-MIOIntraosseousInfusion SystemK052195	Comment
			securely seated inthe bone.
Over-PenetrationSafetyMechanisms	Stepped-needleexists to providesensory feedbackupon cortexpenetration toprevent over-penetration.	No over-penetration safetymechanismexists.	No over-penetration safetymechanismexists.	See comment #2
Insertion Site	In proximal tibia	In the proximaltibia	In proximal tibia	Same
Insertion SiteIdentification	Extending thepatient's leg atthe tibia site, theinsertion site islocatedapproximately1cm medial tothe tibialtuberosity, or justbelow the patella(approximately1cm or onefinger width) andslightly medial(approximately1cm or onefinger width),along the flataspect of thetibia. Theninsertion takesplace.	After extendingthe patient's legat the tibia site,the insertion siteis locatedapproximately 1cm medial to thetibial tuberosity,or (if the tibialtuberosity cannotbe palpated),approximately 1cm medial to thetibial tuberosity,or just below theinferior border ofthe patella(approximately 1cm) and slightlymedial(approximately 1cm) along the flataspect of the	Insertion siteidentification isdefined using thePD-IO whenconnected to theMIO driver.	Same

Item	Subject DeviceWaismed NIO-IK190538	PrimaryPredicateVidaCare Corp.K043490	SecondaryPredicateEZ-MIOIntraosseousInfusion SystemK052195	Comment
		tibia. Pinchingthe tibia betweencaregiver fingersto identify themedial andlateral borders,and insert theneedle in thecenter of thebone.
Materials	Needle:Stainless steel302 (Trocar),stainless steel316L (Cannula)Plasticcomponents:PolycarbonateMakrolonRx2530 andABS PA757(Handle only,no body contactwith thepatient).	Needle (Trocar +catheter):Stainless steel304Hub and Handle:Polycarbonate	Needle (Trocar +catheter):Stainless steel304Hub:Polycarbonate*The needle andHub refer to thePD-IO usedalong with theMIO driverHandle: Plastic	See comment #3
Biocompatibility	Biocompatible.Complies withISO 10993-1	Biocompatible.Complies withISO 10993-1	Biocompatible.Complies withISO 10993-1.	Same
Needle dwellingtime	$≤$ 24Hours	$≤$ 24 Hours	Used along withthePD-IO needle	Same
Item	Subject DeviceWaismed NIO-IK190538	PrimaryPredicateVidaCare Corp.K043490	SecondaryPredicateEZ-MIOIntraosseousInfusion SystemK052195	Comment
			therefore <24 Hours
Hub Interface	The cannula hubis a standard hubLuer Lockappropriate forconnecting toany standardinfusion system.	The cannula hubis a standard hubLuer Lockappropriate for	Hub interface isdefined by thePD-IO usedalong with theMIO driver.	Same
Needle length	15 mm (0.6"),same as PD-IOwith steppedneedle.	15 mm (0.6") forpediatric use	Needle length isdefined by thePD-IO usedalong with theMIO driver forpediatric use: 15mm (0.6").	Same
Needle gauge	18G penetration(and 14G abovethe needle step)	15G	Needle gauge isdefined by thePD-IO usedalong with theMIO driver: 15G.	See comment #4
Single use	Single use	Single use	MIO: ReusablePD-IO: Singleuse	See comment #5
Sterilization	Sterile	Sterile	Sterile	Same
Sterilizationmethod	Gammairradiation	ETO	ETO	See comment #6
SterilePackaging	Sterile barrier	Sterile barrier	Sterile barrier	Same

Table 1: Technological Comparison with the Predicates

Intraosseous infusion device

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Image /page/6/Picture/0 description: The image shows the logo for WaisMed, a PerSys Medical Company. The word "Wais" is in blue, and the word "Med" is in red. Underneath the company name is the text "A PerSys Medical Company" in a smaller, gray font.

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Image /page/7/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. Below the name is the text "A PerSys Medical Company" in a smaller, gray font.

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Image /page/8/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 "Wais" in blue and "Med" in red. Below the company name, the text "A PerSys Medical Company" is written in a smaller, gray font. The logo has a clean and professional design.

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Image /page/9/Picture/0 description: The image shows the logo for WaisMed, a PerSys Medical Company. The word "Wais" is in blue, and the word "Med" is in red. Underneath the name is the text "A PerSys Medical Company" in a smaller, gray font. There is a gray swoosh on the left side of the logo.

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Image /page/10/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 colors, with "Wais" in blue and "Med" in red. Below the company name, the text "A PerSys Medical Company" is written in a smaller, gray font. The logo is simple and professional, reflecting the company's focus on medical products.

Discussion of Technological Characteristics

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

Comment 1

The target population of the NIO-I is narrower than for the predicated devices and it is limited for up to the age of 3 years old, unlike the age of 21 (primary predicate) or both infants and adults (secondary predicate). As indicated in section 6, this difference does not affect the safety and effectiveness of the NIO-I.

Comment 2

NIO-I includes a safety mechanism to provide haptic feedback via the stepped-needle design that helps preventing over-penetration into the distal cortex. The over-penetration safety mechanism reduces the risk of over-penetration, which is a major risk especially for infants.

Comment 3

All materials are basically the same. They differ in specific grade of same generic material. All materials used for the NIO-I passed successfully all applicable biocompatibility tests. Thus, raise no safety issue.

Comment 4

The NIO-I bigger needle gauge (18G), i.e., thinner needle than the predicate device that includes a 15G needle, is more suitable for the NIO-I specific patient population. Aspects related to the needle gauge, were evaluated through V&V tests and are also supported by scientific literature.

Comment 5

Being the NIO-I fully disposable only reduces the risk of contamination due to inappropriate reprocessing.

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Comment 6

Utilizing Gamma irradiation for the NIO-I (similarly to all other WaisMed's cleared products) does not alter the compliance with SAL of 10-0 under this method as well as device materials' resistant to the sterilization agent and process conditions. Since both Gamma irradiation and ETO are considered as acceptable and conventional sterilization methods, this difference does not alter the substantial equivalency principle.

8. Non-Clinical Performance Testing

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.

Biocompatibility tests included, sensitization, hemolysis, material-mediated pyrogenicity, cytotoxicity, acute system toxicity and intracutaneous reactivity.

The biocompatibility tests were conducted to verify that the proposed device is not adverse to 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.
A 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', 'c', 'e', 'f', 'h' below are based on Waismed V&V tests plan.

Tests identified under subsections 'b', 'g', 'i', 'j', 'k', 'l', 'm' are in compliance with applicable standards as follows:

a) Force required for needle cover removal;
b) Visual inspection for corrosion, per ISO 9626;
c) Force required for needle insertion;
d) Minimal force for insertion of the needle;
e) Force for detachment of the needle housing from the needle gripper;

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Image /page/12/Picture/0 description: The image shows the logo for WaisMed, a PerSys Medical Company. The word "Wais" is in blue, and the word "Med" is in red. Underneath the company name, the text "A PerSys Medical Company" is written in a smaller, gray font.

Maximum force for trocar removal after insertion to the platform; f)
g) Cannula effective length, per ISO 9626 and ISO 7864;
h) Maximum force for cannula removal after insertion;
Usability study, per IEC 62366-1; i)
Shelf life, per ISO 11607-1 and ASTM F1980-16; i)
k) Sterilization validation, per ISO 11137-1, ISO 11137-2, ISO 13004, ANSI AAMI ST72;
l) Limits for acidity or alkalinity, per ISO 7864;
m) 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 certain other medical equipment - Part 1: General requirements.
A 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.
A ISO 11137-2:2013 - Sterilization of Health Care Products - Radiation - Part 2: Establishing the Sterilization Dose.
A ISO 13004:2013 - Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD.
ANSI AAMI ST72:2011/(R)2016 Bacterial endotoxins Test methods, routine monitoring, and alternatives to batch testing.
IEC 62366-1:2015 Medical devices Part 1: Application of usability engineering to A medical devices.
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
A ISO 11607-1:2006 - 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.
A 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.

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Image /page/13/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 "Wais" in blue and "Med" in red. Below the company name, the text "A PerSys Medical Company" is written in a smaller, gray font. A partial gray arc is visible on the left side of the logo.

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).