NIPRO SAFETOUCH II GAMMA

K063721 · Nipro Medical Corp. · FIE · Jan 12, 2007 · Gastroenterology, Urology

Device Facts

Record IDK063721
Device NameNIPRO SAFETOUCH II GAMMA
ApplicantNipro Medical Corp.
Product CodeFIE · Gastroenterology, Urology
Decision DateJan 12, 2007
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 876.5540
Device ClassClass 2
AttributesTherapeutic

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 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 Story

NIPRO® SafeTouch II Gamma is a sterile, single-use safety AVF needle for blood access in extracorporeal circuits; used for blood purification. Device features fixed or turnable wings and an active sharps safety mechanism; clinician manually slides a winged cover over the needle upon removal from patient to lock it in place. Transparent protector material allows for easier confirmation of blood flashback compared to predicate. Device is used in clinical settings by healthcare professionals. Benefits include reliable blood access and reduced risk of accidental needlestick injuries to clinicians.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (sterility, bacterial endotoxin, systemic injection, intracutaneous reactivity, hemolysis, implantation, cytotoxicity, sensitization, mutagenicity) and performance testing to verify safety and effectiveness.

Technological Characteristics

Sterile, single-use AVF needle; fixed or turnable wing configurations. Materials include transparent safety protector. Sterilized by ethylene oxide gas. Non-toxic, non-pyrogenic. Mechanical safety latch mechanism.

Indications for Use

Indicated for patients requiring blood purification or treatments involving extracorporeal circuits for large blood volumes. Used by clinicians to provide blood access while reducing accidental needlestick risk via an active safety feature.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ 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 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 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. {1}------------------------------------------------ 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. {2}------------------------------------------------ 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 {3}------------------------------------------------ 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 {4}------------------------------------------------ # Indications for Use 510(k) Number: Kolo372J Device Name: NIPRO® SafeTouch II Gamma 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 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. (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-
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