(67 days)
The Nipro® SafeTouch Safety Fistula Needle is intended for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit or 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 needle stick injuries.
The Nipro® SafeTouch Safety Fistula Needle includes arterial and venous fistula adapter consisting of flexible tube and needle with an active sharps safety feature (non-implanted blood access device) as described in 21 CFR 876.5540. The fistula needle included in this 510(k) is modified to include a change in material of the Safety AVF hub from ABS to PMMA compounds consisting of Methyl Methacrylate Polymer and Butadiene Polymer and a change in the shape of the Safety AVF stopper to enhance the activation of the safety mechanism. The sharps injury prevention system is connected between winged needle and polyvinyl chloride tubing and consists of three parts, the Safety Hub, Safety Stopper and Safety Protector. The needle is attached to the Safety Hub and is connected to the Safety Stopper. The Safety Protector then covers the Safety Hub. 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 latches into place. The Nipro® SafeTouch Safety Fistula Needle includes 2 basic types of design with clamps which remain the same: fixed wing type (stationary) and turnable wing type (rotating) which is offered in 96 configurations with options within it to include needle gauge, needle length, type of needle, and tubing length availability. The devices are packaged sterile and are labeled for single use only.
The provided text describes a 510(k) summary for the Nipro® SafeTouch Safety Fistula Needle, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving efficacy or performance against specific, quantifiable acceptance criteria through detailed clinical studies.
Therefore, the input document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria.
Specifically:
- No acceptance criteria or reported device performance table: The document does not list any specific performance metrics or thresholds for the device.
- No sample size or data provenance for a test set: The document refers to the device being a modified version of a previously cleared one (K002813) and mentions "biocompatibility data support the equivalence," but provides no details of a test set, its size, or origin.
- No information on experts for ground truth or adjudication methods: Since no details of a performance study are provided, this information is not present.
- No Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This type of study is not mentioned or implied.
- No standalone (algorithm only) performance study: This device is a physical medical instrument, not a software algorithm, so this type of study is irrelevant and not included.
- No information on the type of ground truth used: As details of a performance study are missing, information about the ground truth is also absent.
- No sample size for the training set or how ground truth was established for it: The concept of "training set" and associated ground truth establishment is typically relevant to machine learning/AI devices, which this is not. The document focuses on demonstrating equivalence through design and material changes rather than a new performance evaluation with a training set.
The document primarily focuses on:
- Device Classification and Intended Use: Defining what the device is and what it's used for.
- Device Description and Characteristics: Highlighting changes from the predicate device (e.g., material change from ABS to PMMA for the Safety AVF hub, and a change in the shape of the Safety AVF stopper).
- Substantial Equivalence Argument: Stating that the modified device is substantially equivalent to the predicate in terms of intended use, materials, biocompatibility, and overall performance. Biocompatibility data is mentioned as supporting this equivalence, but no detailed study results or acceptance criteria are presented.
In summary, the provided filing is a 510(k) summary, which aims to demonstrate substantial equivalence to an existing device rather than presenting a de novo performance study against defined acceptance criteria. Therefore, the detailed information requested about acceptance criteria and associated study specifics is not available in this document.
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K032777
Page 1 of 2
510(k) Summary of Safety and Effectiveness
1. Manufacturer and Contact Information:
| Manufacturer: | Nipro (Thailand) Corporation Limited10/2 Moo 8, Bangnomko, SenaAyuthaya, Thailand 13110 |
|---|---|
| U. S. Distributor: | Nipro Medical Corporation3150 NW 107 AvenueMiami, FL 33172 |
| Contact Information: | Richard D. Bliss, Jr.Quality Systems Engineering510 Stonemont DriveWeston, FL 33326Telephone: (954) 385-1690Fax: (954) 385-1256 |
2. Device Classification Name:
The Gastroenterology and Urology Devices Panel has classified Blood Access Device and accessories as Class II. Reference 21 CFR 876.5540.
3. Intended Use:
The Nipro® SafeTouch Safety Fistula Needle is intended for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit or 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 needle stick injuries.
4. Device Description and Characteristics:
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements for the Safe Medical Device Act (SMDA) 1990.
The Nipro® SafeTouch Safety Fistula Needle includes arterial and venous fistula adapter consisting of flexible tube and needle with an active sharps safety feature (non-implanted blood access device) as described in 21 CFR 876.5540. The Nipro® SafeTouch Safety Fistula Needle was previously described in detail as part of Premarket Notification cleared by FDA under K002813 on November 21, 2000.
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Page 2 of 2
The fistula needle included in this 510(k) is modified to include a change in material of the Safety AVF hub from ABS to PMMA compounds consisting of Methyl Methacrylate Polymer and Butadiene Polymer and a change in the shape of the Safety AVF stopper to enhance the activation of the safety mechanism.
The sharps injury prevention system is connected between winged needle and polyvinyl chloride tubing and consists of three parts, the Safety Hub, Safety Stopper and Safety Protector. The needle is attached to the Safety Hub and is connected to the Safety Stopper. The Safety Protector then covers the Safety Hub.
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 latches into place. The safety feature presented in this document represents a substantially equivalent version of the current brand, which previously cleared FDA in K002813.
The Nipro® SafeTouch Safety Fistula Needle includes 2 basic types of design with clamps which remain the same: fixed wing type (stationary) and turnable wing type (rotating) which is offered in 96 configurations with options within it to include needle gauge, needle length, type of needle, and tubing length availability. A table with all the device configurations is included in Section 3 of this report.
The devices are packaged sterile and are labeled for single use only. There is no ability to clean and reuse these devices. They are restricted for sale by or on the order of a physician. The results of biocompatibility data support the equivalence of the predicate device and include sterility safety, pyrogenicity, intracutaneous reactivity, systemic iniection, hemolysis, implantation testing. Please refer to Tab 9 of the Biocompatibility Section.
5. Substantial Equivalence
Nipro Medical Corporation considers the modified Nipro® SafeTouch Safety Fistula Needle to be substantially equivalent to the current Nipro SafeTouch Safety Fistula Needle with regard to intended use, materials, biocompatibility, and overall performance characteristics. The labeling is equivalent to the predicate device in intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2003
Nipro Medical Corp. c/o Richard D. Bliss, Jr. Quality Systems Engineering 510 Stonemont Drive WESTON FL 33326
Re: K032777
Trade/Device Name: Nipro SafeTouch Safety Fistula Needles Regulation Number: 21 CFR 876.5540 Regulation Name: Blood access device and accessories Product Code: 78 FIE Regulation Number: 21 CFR §880.5200 Regulation Name: Intravascular catheter Product Code: 80 FOZ Regulatory Class: II Dated: October 13, 2003 Received: October 15, 2003
Dear Mr. Bliss:
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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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.
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Page 2
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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Nipro® SafeTouch Safety Fistula Needle Device Name:
Indications for Use:
The Nipro® SafeTouch Safety Fistula Needles is intended for use as a blood access device for blood purification and for other treatments requiring extracorporeal circuit. The Nipro SafeTouch Safety Fistula Needle aids in the prevention of accidental needle stick injuries. 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 (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96)
Nancy C Brogdon
Division Stop Off
(Division Stgn-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K032770
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).