Who is the manufacturer of NIO-I?

Waismed, Ltd. filed the 510(k) submission for NIO-I (K190538).

What is the FDA product code for NIO-I?

FMI. It is classified under 21 CFR 880.5570 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for NIO-I?

510(k) clearance (submission type: Traditional).

What are the predicate devices for NIO-I?

PD-IO, Disposable Intraosseous Infusion Needle and Handle (K043490); EZ-MIO Manual Driver (K052195).

Who can help prepare an FDA 510(k) submission like NIO-I?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NIO-I

K190538 · Waismed, Ltd. · FMI · Oct 7, 2019 · General Hospital

Device Facts

Record ID	K190538
Device Name	NIO-I
Applicant	Waismed, Ltd.
Product Code	FMI · General Hospital
Decision Date	Oct 7, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5570
Device Class	Class 2
Attributes	Therapeutic, Pediatric

Intended Use

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 Story

Manual intraosseous device; provides vascular access in proximal tibia of infants. Device includes ergonomic handle, trocar needle, and cannula. Operation: manual insertion through bone cortex until haptic feedback from stepped-needle design indicates penetration into medullary cavity; handle disconnected; trocar removed; cannula remains in bone for fluid/drug infusion. Used in hospital, clinic, or emergency care settings by healthcare providers. Stepped-needle design provides sensory feedback to prevent over-penetration into distal cortex, reducing injury risk in infants. Fully disposable design minimizes contamination risk.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including biocompatibility (ISO 10993), usability (IEC 62366-1), and mechanical performance testing (force for insertion/removal, needle integrity, conical fitting, shelf life).

Technological Characteristics

Manual intraosseous needle. Materials: Stainless steel 302 (trocar), 316L (cannula); Polycarbonate Makrolon Rx2530 and ABS PA757 (handle). Stepped-needle design for haptic feedback. 18G needle gauge. Sterile (Gamma irradiation). Single-use. Complies with ISO 10993, ISO 594-1/2, ISO 9626, ISO 7864, ISO 11137, and ASTM F1980.

Indications for Use

Indicated for infants (gestational age >= 36 weeks, weight >= 2.3 kg, age <= 3 years) requiring emergency vascular access in the proximal tibia when IV access is not feasible.

Regulatory Classification

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.

Predicate Devices

PD-IO, Disposable Intraosseous Infusion Needle and Handle (K043490)
EZ-MIO Manual Driver (K052195)

Related Devices

K211395 — NIO-I · Einstein Works, LLC · Jul 28, 2021
K160887 — Cook Intraosseous Infusion Needles · Cook Incorporated · Jul 26, 2016
K182770 — Adult Intraosseous Infusion Device · Einstein Works, LLC · Apr 9, 2019
K191258 — Intraosseous infusion device · Einstein Works, LLC · Oct 23, 2019
K043490 — PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE · Vidacare Corporation · Feb 18, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K190538 Device Name NIO-I Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |----------------------------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 {4}------------------------------------------------ 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 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. | Characteristics | Subject Device Waismed NIO-I K190538 | Primary Predicate VidaCare Corp. K043490 | Secondary Predicate EZ-MIO Intraosseous Infusion System K052195 | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | 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. | The PD-IO Disposable Intraosseous Infusion Needle and Handle provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients. | For pediatric use: The PD-IO™ infusion system provides intraosseous access in proximal tibia, as an alternative to IV access during emergencies to pediatric patients, from birth to 21 years of age (approximate weight range: 3 kg - 39 kg). For adult use: The EZ- IOTM Infusion System provides intraosseous access in the proximal tibia, as an alternative to IV access during emergencies to adult patients (22 years of age or older, > 40 kg) *Note: the adult use part of the indications for use is not included in this submission. | ### 6. Indications for Use Statement {5}------------------------------------------------ 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 Device Waismed NIO-I K190538 | Primary Predicate VidaCare Corp. K043490 | Secondary Predicate EZ-MIO Intraosseous Infusion System K052195 | |---------------------------------------------|--------------------------------------------|------------------------------------------------|--------------------------------------------------------------------------| | Prescription Only or Over the counter | 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 Device Waismed NIO-I K190538 | Primary Predicate VidaCare Corp. K043490 | Secondary Predicate EZ-MIO Intraosseous Infusion System K052195 | Comment | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------| | Target Population | Emergency Care for infant patients (0-3 years of age) | Emergency Care for pediatric patients (0-21 years of age) | Emergency Care for pediatric and adult patients | See comment #1 | | Anatomical Sites | Proximal Tibia | Proximal Tibia | Proximal Tibia | Same | | Environment Used | Hospital, Clinic, Emergency Care | Hospital, Clinic, Emergency Care | Hospital, Clinic, Emergency Care | Same | | Design | Consists of trocar needle, stylet and | Consists of trocar needle, stylet and catheter, needle | Consists of a pentagon shaft permanently | Same | | Item | Subject Device Waismed NIO-I K190538 | Primary Predicate VidaCare Corp. K043490 | Secondary Predicate EZ-MIO Intraosseous Infusion System K052195 | Comment | | | catheter, needle cover and a handle. | cover and a handle. | attached to a handle and connected to the PD-IO (for pediatrics) | | | Mechanism of Action | Manually in three stages: (1) The NIO-I needle is manually inserted through the cortex of the bone until change is resistance is felt, indicating the needle penetrated the bone marrow cavity. (2) The insertion handle is then disconnected from the needle and, (3) the trocar is removed by pulling it upwards. | Manually in three stages: (1) The PD-IO needle is manually inserted through the cortex of the bone to a desired depth within the bone marrow. (2) The insertion handle with trocar is then separated from the catheter hub by turning the handle counter clockwise and then, (3) being removed, leaving the a standard luer lock catheter securely seated in the bone. | Manual needle insertion using stylet and catheter into the bone cortex to a desired depth within the bone marrow. After insertion of the needle set the manual driver is detached from the needle set leaving the stylet and cannula firmly seated in the bone. The stylet is then separated and removed from the catheter by turning the stylet hub counter clockwise, leaving a standard luer lock catheter | Same | | Item | Subject Device Waismed NIO-I K190538 | Primary Predicate VidaCare Corp. K043490 | Secondary Predicate EZ-MIO Intraosseous Infusion System K052195 | Comment | | | | | securely seated in the bone. | | | Over- Penetration Safety Mechanisms | Stepped-needle exists to provide sensory feedback upon cortex penetration to prevent over- penetration. | No over- penetration safety mechanism exists. | No over- penetration safety mechanism exists. | See comment #2 | | Insertion Site | In proximal tibia | In the proximal tibia | In proximal tibia | Same | | Insertion Site Identification | Extending the patient's leg at the tibia site, the insertion site is located approximately 1cm medial to the tibial tuberosity, or just below the patella (approximately 1cm or one finger width) and slightly medial (approximately 1cm or one finger width), along the flat aspect of the tibia. Then insertion takes place. | After extending the patient's leg at the tibia site, the insertion site is located approximately 1 cm medial to the tibial tuberosity, or (if the tibial tuberosity cannot be palpated), approximately 1 cm medial to the tibial tuberosity, or just below the inferior border of the patella (approximately 1 cm) and slightly medial (approximately 1 cm) along the flat aspect of the | Insertion site identification is defined using the PD-IO when connected to the MIO driver. | Same | | | | | | | | Item | Subject Device Waismed NIO-I K190538 | Primary Predicate VidaCare Corp. K043490 | Secondary Predicate EZ-MIO Intraosseous Infusion System K052195 | Comment | | | | tibia. Pinching the tibia between caregiver fingers to identify the medial and lateral borders, and insert the needle in the center of the bone. | | | | Materials | Needle: Stainless steel 302 (Trocar), stainless steel 316L (Cannula) Plastic components: Polycarbonate Makrolon Rx2530 and ABS PA757 (Handle only, no body contact with the patient). | Needle (Trocar + catheter): Stainless steel 304 Hub and Handle: Polycarbonate | Needle (Trocar + catheter): Stainless steel 304 Hub: Polycarbonate *The needle and Hub refer to the PD-IO used along with the MIO driver Handle: Plastic | See comment #3 | | Biocompatibility | Biocompatible. Complies with ISO 10993-1 | Biocompatible. Complies with ISO 10993-1 | Biocompatible. Complies with ISO 10993-1. | Same | | Needle dwelling time | $≤$ 24 Hours | $≤$ 24 Hours | Used along with the PD-IO needle | Same | | Item | Subject Device Waismed NIO-I K190538 | Primary Predicate VidaCare Corp. K043490 | Secondary Predicate EZ-MIO Intraosseous Infusion System K052195 | Comment | | | | | therefore <24 Hours | | | Hub Interface | The cannula hub is a standard hub Luer Lock appropriate for connecting to any standard infusion system. | The cannula hub is a standard hub Luer Lock appropriate for | Hub interface is defined by the PD-IO used along with the MIO driver. | Same | | Needle length | 15 mm (0.6"), same as PD-IO with stepped needle. | 15 mm (0.6") for pediatric use | Needle length is defined by the PD-IO used along with the MIO driver for pediatric use: 15 mm (0.6"). | Same | | Needle gauge | 18G penetration (and 14G above the needle step) | 15G | Needle gauge is defined by the PD-IO used along with the MIO driver: 15G. | See comment #4 | | Single use | Single use | Single use | MIO: Reusable PD-IO: Single use | See comment #5 | | Sterilization | Sterile | Sterile | Sterile | Same | | Sterilization method | Gamma irradiation | ETO | ETO | See comment #6 | | Sterile Packaging | Sterile barrier | Sterile barrier | Sterile barrier | Same | #### Table 1: Technological Comparison with the Predicates Intraosseous infusion device {6}------------------------------------------------ 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. {7}------------------------------------------------ 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. {8}------------------------------------------------ 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. {9}------------------------------------------------ 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. {10}------------------------------------------------ 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. {11}------------------------------------------------ # 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; {12}------------------------------------------------ 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. {13}------------------------------------------------ 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. ............... ..............................................................................................................................................................................

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