(62 days)
The Nipro Safelet Cath is intended to be inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids intravenously.
The devices we intend to market are intravascular catheters as described in 21 CFR 880.5200. The subject devices are similar to catheters currently marketed by Nipro Medical Corporation under K960051. Two types of catheters will be available: the container cases types L (long) and S (short). Type L catheters have needles 1 1/2 to 2 1/2 inches long and Type S have needles ¾ to 1 ¼ inches long. Six gauges of catheters are described here (14, 16, 18, 20, 22 and 24 gauge). The tip of the cannula is beveled. The proximal end of the catheter has a filter cap.
This is a premarket notification for a medical device (Nipro Safelet Cath), not an AI/ML medical device. Therefore, the information typically requested regarding acceptance criteria and studies proving performance for AI devices (such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or available in this document.
The document is a 510(k) summary demonstrating substantial equivalence to a legally marketed predicate device (K960051), rather than presenting novel performance data against specific acceptance criteria for an AI algorithm.
However, I can extract information relevant to the device itself as presented in the document:
1. A table of acceptance criteria and the reported device performance:
This document describes a medical device (intravascular catheter) and focuses on demonstrating its substantial equivalence to a previously marketed device (K960051). It does not present specific quantitative acceptance criteria or detailed performance results in the way an AI diagnostic device submission would. Instead, the "performance" here is implied by the similarity in technical characteristics and intended use to the predicate device.
| Acceptance Criterion (Implied by Substantial Equivalence) | Reported Device Performance (as per comparison to predicate) |
|---|---|
| Intended Use: Inserted into patient's vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids intravenously. | Meets: Intended use is identical to the predicate device. |
| Device Type: Intravascular catheter. | Meets: Classified as an intravascular catheter. |
| Physical Characteristics: | Meets: Two types (L and S) with varying needle lengths (1 1/2 to 2 1/2 inches, ¾ to 1 ¼ inches) and six gauges (14, 16, 18, 20, 22, 24 gauge). Beveled tip, filter cap. These are described as "similar" to the predicate. |
| Material/Design: | Meets: Described as "similar" to catheters currently marketed by Nipro Medical Corporation under K960051. |
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device, and no "test set" in the context of algorithm performance is mentioned. The submission relies on comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set requiring expert adjudication for ground truth is mentioned.
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: Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
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DEC 0 3 2001
K013287 SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO SAFELET CATH
$ 807.92 (a) (1)
Contact Person: Eiji Shinozaki
Date of Summary Preparation:
& 807.92 (a)(2)
Trade Name:
Common Name:
Classification Name:
eptember 27, 2001
NIPRO MEDICAL CORPORATION 3150 N.W. 107 Avenue Miami, Florida 33172 Tel .: (305) 599-7174 Fax: (305) 599-8454
Nipro Safelet Cath
Intravascular catheter
Intravascular catheter (for short-term use) (§ 880.5200)
§ 807.92 (a)(3)
Legally Marketed Substantially Equivalent Device: Marketed in U.S. under K960051.
$ 908.92 (a)(4)
Description of Device:
The devices we intend to market are intravascular catheters as described in 21 CFR 880.5200. The subject devices are similar to catheters currently marketed by Nipro Medical Corporation under K960051. Two types of catheters will be available: the container cases types L (long) and S (short). Type L catheters have needles 1 1/2 to 2 1/2 inches long and Type S have needles ¾ to 1 ¼ inches long. Six gauges of catheters are described here (14, 16, 18, 20, 22 and 24 gauge). The tip of the cannula is beveled. The proximal end of the catheter has a filter cap.
$ 807.92 (a)(5)
Intended Use:
The Nipro Safelet Cath is intended to be inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids intravenously.
§ 807.92 (a)(6)
Comparison of Technical Characteristics:
Nipro Safelet Cath produced in Brazil and in Thailand are similar. Nipro Medical Corporation manufactures the subject devices in Brazil rather than in Thailand. Given the similarities outlined in Table 7, there is no question of their substantial equivalence.
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of what appears to be a bird or abstract design, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 3 2001
Ms. Kaelyn B. Hadley Consultant Nipro Medical Corporation 1384 Copperfield Court Lexington, Kentucky 40514
Re: K013287
Trade/Device Name: Nipro Safelet Cath Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: September 27, 2001 Received: October 2, 2001
Dear Ms. Hadley:
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 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.
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.
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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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). 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
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) number (if known): ΚΩΙ??? Η Ο Α 3 ΑΣ 7 Device name: Nipro® Safelet Cath
Device hame: I sipro - Barelet Cath is intended to be inserted into a patient's vascular rindications for abort-term use to sample blood or administer fluids intravenously.
(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 1-2-9 )
Atricia Lucent
(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control, and General Hospital ក្រូវលូ(k) Number
§ 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).