(153 days)
The Nipro Luer Adaptor is intended to be used as an attachment for a needle with a luer taper hub for blood collection. The luer adaptor is used as part of the vacuum blood collection equipment for blood collection required for various blood tests.
The Nipro Luer Adaptor that we intend to market is a multi-type with a cannula that has an outer diameter of 0.90 mm and a back end length of 20 mm to 24 mm. The Luer Adaptor is intended to be used as an attachment for a needle with a luer taper hub for blood collection. The luer adaptor is used as part of the vacuum blood collection equipment for blood collection required for various blood tests. The luer adaptor is used to connect to a blood collection needle that has a female luer taper for use. As such, this product has a hub with a male luer taper. The product is a sterilized single-use product. The materials used for the components include stainless steel SUS 304 (SS), synthetic rubber, and polypropylene (PP). Epoxy resin as an adhesive and silicone oil as a lubricant are also used.
This document (K992729) is a 510(k) premarket notification for a medical device called the "Nipro Luer Adaptor." It describes the device's intended use and claims substantial equivalence to a predicate device.
Based on the provided text, the document does not contain a study design, acceptance criteria, or performance data for the Nipro Luer Adaptor.
Instead, it's a submission to the FDA for a new device, arguing its similarity to an already approved device (the Exel International Luer Adaptor K861152A). The key statement that dictates the type of "proof" offered is:
"The Nipro and Exel devices are exactly the same devices, therefore, all technical characteristics are identical."
This means the acceptance criteria and "study" described are implicitly met by virtue of the Nipro Luer Adaptor being identical to a device already deemed safe and effective by the FDA. There is no independent performance evaluation described for the Nipro Luer Adaptor itself, as its substantial equivalence is based on its direct identity to the predicate device.
Therefore, I cannot fill out the requested table or answer most of the questions because the document explicitly states the two devices are identical.
Here's what can be inferred or stated from the document:
- Acceptance Criteria: Implicitly, the Nipro Luer Adaptor must meet all the technical characteristics and performance standards of the predicate device, the Exel International Luer Adaptor (K861152A). These criteria are not explicitly listed but are assumed to have been met by the predicate device when it was cleared.
- Study Proving Acceptance Criteria: The "study" is the assertion of technical identity between the Nipro Luer Adaptor and the legally marketed predicate device, Exel International Luer Adaptor (K861152A). By stating they are "exactly the same devices" and "all technical characteristics are identical," the Nipro Medical Corporation is arguing that no new performance study is needed for the Nipro device specifically.
Table of Acceptance Criteria and Reported Device Performance (Based on the document's assertion of identity):
| Acceptance Criteria (Implicit, based on predicate device K861152A) | Reported Device Performance (Nipro Luer Adaptor) |
|---|---|
| Intended Use: Attachment for needle with luer taper hub for blood collection. | Meets intended use by being "exactly the same" as the predicate device (Exel International Luer Adaptor) which is cleared for this indication. |
| Material Composition (Stainless steel SUS 304, synthetic rubber, polypropylene, epoxy resin, silicone oil). | Identical materials are used as the predicate device. |
| Design (e.g., cannula outer diameter 0.90 mm, back end length 20-24 mm, male luer taper hub). | "Exactly the same design" as the predicate device, including cannula outer diameter of 0.90 mm and back end length of 20 mm to 24 mm. It functions as a connector to a blood collection needle with a female luer taper, having a male luer taper hub itself. |
| Sterilized single-use product. | "Exactly the same" as the predicate device, indicating it is a sterilized single-use product. |
| Performance (e.g., fluid integrity, connection strength, biocompatibility, sterility) | Implied to be identical to the predicate device. The document explicitly states "all technical characteristics are identical," which would encompass performance aspects. No specific performance metrics or test results are provided for the Nipro device itself in this submission. |
Answers to Specific Questions (Based on available information in K992729):
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable / Not provided. No specific test set or data provenance is mentioned as the approval relies on substantial equivalence by identity to a predicate device, not on new performance data for the Nipro Luer Adaptor.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable / Not provided. Ground truth establishment for a test set is not described, as there is no independent performance testing reported.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable / Not provided. No adjudication method for a test set is mentioned.
- 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 document is for a physical medical device (luer adaptor), not an AI/software device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is for a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable / Not provided. Since no new performance studies are presented for the Nipro device, no ground truth types are described. The "ground truth" for its safety and effectiveness is implicitly derived from the prior clearance of the identical predicate device.
- The sample size for the training set: Not applicable / Not provided. No training set is mentioned as this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable / Not provided. No training set ground truth establishment is mentioned.
{0}------------------------------------------------
JAN 1 3 2000
Image /page/0/Picture/2 description: The image shows the word "NIPRO" in bold, sans-serif font, next to a stylized logo. The logo is composed of two interlocking shapes that resemble the infinity symbol or a figure eight. The logo and the word "NIPRO" are both in black, contrasting with the white background.
NIPRO MEDICAL CORPORATION 10877 N.W. 33rd Street Miami. Florida 33172 Tel .: (305) 599-7174 Fax: (305) 599-8454
SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO® LUER ADAPTOR
8807.92 (a)(1)
Contact Person:
Luis Candelario General Manager
August 2, 1999 Date of Summary Preparation:
$807.92 (a)(2)
Nipro® Luer Adaptor Trade Name: Common Name: Luer adaptor Classification Name: Intravascular Administration Set (21 CFR 880.5440) Establishment Registration Number: 9611446 Class: II Panel: 80 Procodes: FOZ
8807.92 (a)(3)
Legally Marketed Substantially Equivalent Device: Exel International Luer Adaptor (K861152A)
8807.92 (a)(4)
Description of Device: The Nipro Luer Adaptor that we intend to market is a multi-type with a cannula that has an outer diameter of 0.90 mm and a back end length of 20 mm to 24 mm.
The Luer Adaptor is intended to be used as an attachment for a needle with a luer taper hub for blood collection. The luer adaptor is used as part of the vacuum blood collection equipment for blood collection required for various blood tests. The luer adaptor is used to connect to a blood collection needle that has a female luer taper for use. As such, this product has a hub with a male luer taper. The product is a sterilized single-use product.
{1}------------------------------------------------
| Luer Adaptors are described in Intravascular AdministrationSet (21 CFR 880.5440). | |
|---|---|
| The materials used for the components include stainlesssteel SUS 304 (SS), synthetic rubber, and polypropylene(PP). Epoxy resin as an adhesive and silicone oil as alubricant are also used. | |
| §807.92 (a)(5) | |
| Intended Use: | The luer adaptor is intended to be used as an attachment for aneedle with a luer taper hub for blood collection. The luer adaptoris used as part of the vacuum blood collection equipment for bloodcollection required for various blood tests intended to be used tocollect blood for various types of blood tests. |
| §807.92 (a)(6) | |
| Comparison of Technical Characteristics: |
The Nipro and Exel devices are exactly the same devices, therefore, all technical characteristics are identical.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person's profile. The symbol is positioned in the center of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2000
Nipro Medical Corporation c/o Ms. Kaelyn B. Hadley Consultant for Nipro Medical Corporation C.L. McIntosh & Associates, Incorporated Medical & Requlatory Affairs Services 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852
K992729 Re :
Trade Name: Nipro® Luer Adaptor Requlatory Class: II Product Code: FMI November 24, 1999 Dated: November 26, 1999 Received:
Dear Ms. Hadley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturinq Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in
{3}------------------------------------------------
Page 2 - Ms. Hadley
the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to beqin marketinq your device as described in your 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 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
K 992729 510(k) Number (if known) _ Device Name: Nipro Luer Adaptor
Indications for Use: The Nipro Luer Adaptor is intended to be used as an attachment for a needle with a luer taper hub for blood collection. The luer adaptor is used as part of the vacuum blood collection equipment for blood collection required for various blood tests.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
-4-
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use
Patrice Cusmite
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Dev 6 - Number --
§ 880.5570 Hypodermic single lumen needle.
(a)
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.(b)
Classification. Class II (performance standards).