The NIPRO® Safetouch II Gamma is intended for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood. Secondly, it is designed with an active sharps safety feature requiring physical action by the clinician to aid in the prevention of accidental needlesticks. The compatibility of available configurations is the responsibility of the physician in charge.

Device Description

The NIPRO® SafeTouch II Gamma is a sterile, single use, safety AVF needle. It includes 2 basic types of designs; fixed wing type (stationary) and turnable wing type (rotating). These two designs are offered in 64 configurations with options that include needle gauge, needle length, type of needle (with or without backeye), and tubing length. The NIPRO® SafeTouch II Gamma includes an arterial and venous fistula adapter consisting of flexible tube and needle with an active sharps safety feature (nonimplanted blood access device) as described in 21 CFR 876.5540. The safety feature is easily operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks into place. The only difference being the material used for the protector which has changed from a frosted to a transparent component, making it easier to confirm blood flash black. These devices operate on the principles of a blood access device. They are sterile, single use only, non-toxic and non-pyrogenic.

AI/ML Overview

This document describes the NIPRO® SafeTouch II Gamma, a sterile, single-use safety AVF needle, and compares it to a legally marketed substantial equivalent device, the NIPRO® SafeTouch Safety AVF Needle (K032777).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated with numerical targets in this document. Instead, the performance is demonstrated through a comparison of technological characteristics and non-clinical tests, concluding substantial equivalence to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Device materials are safe for patient contact.	Compliant: Biocompatibility data support the equivalence to the predicate device, including sterility safety, bacterial endotoxin, systemic injection, intracutaneous reactivity, hemolysis, implantation, cytotoxicity, sensitization, and mutagenicity testing.
Sterility: Device is sterile.	Compliant: Confirmed through sterility safety testing.
Safety Feature Functionality: The sharps safety feature effectively prevents accidental needlesticks.	Compliant: The safety feature is easily operated through a latch mechanism where a winged cover slides over the needle and locks into place. The design is substantially equivalent to the cleared predicate device (K032777), with a minor material change to the protector (frosted to transparent).
Overall Performance: Device performs effectively for intended use.	Compliant: Performance testing was conducted to verify the device is safe and effective for its intended use. The results demonstrate equivalent performance to the predicate device.
Material Equivalence: Materials are comparable to the predicate device.	Compliant: The document states "materials of construction" are comparable to the predicate device.
Intended Use Equivalence: Device has the same intended use as the predicate device.	Compliant: The document explicitly states the "intended use" is comparable to the predicate device.
Labeling Equivalence: Labeling is comparable to the predicate device.	Compliant: The document states "labeling" is comparable to the predicate device.
Non-toxic and Non-pyrogenic: Device is free from toxic substances and does not induce fever.	Compliant: Explicitly stated that the devices are "non-toxic and non-pyrogenic."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set of the NIPRO® SafeTouch II Gamma. It refers generally to "performance testing" and "biocompatibility data." The data provenance is not specified beyond indicating that "Those reports along with associated data are included in this submission." It is implied that these are prospective tests performed on the NIPRO® SafeTouch II Gamma, as part of its premarket notification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. As this is a medical device submission focused on substantial equivalence based on non-clinical testing and comparison to a predicate, the "ground truth" for the test set largely comes from established scientific and engineering principles for material safety and device functionality, rather than human expert interpretation of clinical data on the device itself.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers or expert consensus on observations (e.g., image interpretation). This document focuses on the results of non-clinical testing and material property comparisons.

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

An MRMC comparative effectiveness study was not done and is not applicable to this device. This is a medical device for blood access, not an AI-driven diagnostic or interpretative tool. Therefore, there is no "human readers improve with AI vs without AI assistance" effect size to report.

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

A standalone performance study, as typically understood for an algorithm without human intervention, was not done and is not applicable. This is a physical medical device, not a software algorithm. Its performance is intrinsic to its design and materials.

7. The Type of Ground Truth Used

The ground truth for this device is based on:

Established scientific and engineering standards: For biocompatibility (e.g., ISO standards for cytotoxicity, sensitization, etc.).
Performance specifications: For the mechanical functionality of the safety feature and the needle itself (e.g., strength, sharpness, ease of activation).
Predicate device characteristics: The NIPRO® SafeTouch Safety AVF Needle (K032777) serves as the primary reference for "ground truth" regarding acceptable performance and characteristics for this type of device.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The NIPRO® SafeTouch II Gamma is a physical medical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established

This information is not applicable and therefore not provided. As there is no AI model or training set, there is no ground truth for a training set to be established.

Summary

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Image /page/0/Picture/0 description: The image shows handwritten text. The text at the top reads "KDL63721". Below that, the text reads "page 1 of 2". The handwriting is somewhat cursive and slightly difficult to read.

Image /page/0/Picture/1 description: The image shows the logo and contact information for Nipro Medical Corporation. The logo features a stylized, abstract design to the left of the company name, "NIPRO," in bold, sans-serif font. Below the logo, the address is listed as 3150 N.W. 107 Avenue, Miami, Florida 33172, followed by the telephone number (305) 599-7174 and fax number (305) 599-8454.

JAN 1 2 2007

510(k) Summary of Safety and Effectiveness for the NIPRO® SafeTouch II Gamma

807.92(a)(1)

Applicant: Establishment Reg.: Nipro Medical Corporation 1056186

Contact Person:

Jessica Oswald Regulatory Affairs Specialist

Date of summary preparation: December 8, 2006

807.92(a)(2)

Trade Name: NIPRO® Safetouch II Gamma Common Name: Safety Fistula Needle Classification Number: 21 CFR 876.5540 Classification Name: Blood access device and accessories Panel: 78 Product Code: FIE

807.92(a)(3)

Leqally marketed substantial equivalent device: NIPRO® SafeTouch Safety AVF Needle (K032777)

807.92(a)(4)

Description of device:

The NIPRO® SafeTouch II Gamma includes an arterial and venous fistula adapter consisting of flexible tube and needle with an active sharps safety feature (nonimplanted blood access device) as described in 21 CFR 876.5540. The predicate device, NIPRO® SafeTouch Safety Fistula Needle, which is sterilized by Ethylene oxide gas was previously described in detail as part of Premarket Notification cleared by FDA under K032777 on November 14, 2003.

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K063721
page 2 of 2

Image /page/1/Picture/1 description: The image shows the logo and contact information for Nipro Medical Corporation. The logo features a stylized, abstract design next to the word "NIPRO" in bold, sans-serif font. Below the logo is the company name, address (3150 N.W. 107 Avenue, Miami, Florida 33172), telephone number ((305) 599-7174), and fax number ((305) 599-8454).

The safety feature is easily operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks into place. The safety feature presented in this document represents a substantially equivalent version of the current brand, which is cleared under K032777. The only difference being the material used for the protector which has changed from a frosted to a transparent component, making it easier to confirm blood flash black.

These devices operate on the principles of a blood access device. They are sterile, single use only, non-toxic and non-pyrogenic.

807.92(a)(5)

Indications for Use:

The NIPRO® Safetouch II Gamma is intended for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood. Secondly, it is designed with an active sharp safety feature requiring physical action by the clinician to aid in the prevention of accidental needlesticks. The compatibility of available configurations is the responsibility of the physician in charge.

807.92(a)(6)

Comparison of technological characteristics:

Nipro Medical Corporation considers the modified NIPRO® SafeTouch II Gamma to be substantially equivalent to the current NIPRO® SafeTouch Safety Fistula Needle (K032777) with regard to intended use, materials of construction, labeling, and overall performance characteristics.

807.92(b)(1)

Non-clinical tests submitted:

The results of biocompatibility data support the equivalence of the predicate device and include sterility safety, bacterial endotoxin, systemic injection, intracutaneous reactivity, hemolysis, implantation, cytotoxicity, sensitization and mutagenicity testing. Performance testing was also conducted to verify that the device is safe and effective for its intended use. Those reports along with associated data are included in this submission.

807.92(b)(3)

Conclusions drawn from non-clinical and clinical tests:

The results of the performance testing and the comparison of technological characteristics demonstrate that the NIPRO® SafeTouch II Gamma performs equivalent to the predicate device and is safe and effective when used as intended.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Jessica Oswald Regulatory Affairs Specialist NIPRO Medical Corporation 3150 N.W. 107 Avenue MIAMI FL 33172

JAN 1 2 2007

Re: K063721

Trade/Device Name: NIPRO® SafeTouch II Gamma Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: FIE Dated: December 13, 2006 Received: December 15, 2006

Dear Ms. Oswald:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo, with the word "Centennial" underneath. There are three stars below the word "Centennial". The text "In the service of public health" is at the bottom of the logo.

moting Public

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Page 2 --

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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: Kolo372J

Device Name: NIPRO® SafeTouch II Gamma

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

(Division Sign Off)
Division of Abdominal,
and
510(k) Number R063221

NIPRO® SafeTouch II Gamma

-4.1-

Regulation Number and Section

§ 876.5540 Blood access device and accessories.

(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.