This device is intended for injection of insulin. The needle protection device is an integral pre-attached to the needle. Once the needle/needle protection device is attached to a syringe, the collar hoop hinders removal of the needle protection device from the needle. The Needle-Pro® sheath may be adjusted relative to the desired position. After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. As the needle enters the protective sheath, the needle protection device engages and the needle is contained within the sheath. The device should be immediately disposed into a sharps container. The device is supplied with 26G and 27G needles.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Hypodermic Needle-Pro® Insulin Syringe & Needle with Needle Protection Device). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically seen in performance studies for diagnostic or AI-driven devices.

Here's a breakdown of the requested information based only on the provided text, highlighting what is missing:

Acceptance Criteria and Device Performance Study

The provided document does not describe an acceptance criteria table or a study designed to prove the device meets specific performance criteria in the way requested (e.g., sensitivity, specificity, or similar metrics for diagnostic tools). This document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance against predefined metrics.

The document states:

"NON-CLINICAL DATA: The descriptive characteristics of this device are precise enough to ensure equivalence."
"CLINICAL DATA: Not applicable"
"CONCLUSION: The comparison to the predicate devices demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device."

This indicates that the "study" conducted for this 510(k) was primarily a comparative analysis of the device's characteristics against a predicate device to establish substantial equivalence. Performance criteria related to safety and effectiveness are inferred through this equivalence, rather than direct measurement against numerical targets.

Breakdown of Requested Information:

A table of acceptance criteria and the reported device performance
- Not provided. The document does not define specific quantitative acceptance criteria or report performance metrics in this format. The basis for approval is substantial equivalence to a predicate device.
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. Since no specific clinical or performance study with a "test set" was described, this information is absent. The assessment relied on comparison with a predicate device.
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. No ground truth establishment by experts for a test set is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set or adjudication method is described.
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 / Not provided. This device is an insulin syringe with a needle protection mechanism, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. This device is a physical medical instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. For this type of device and submission, "ground truth" as typically understood in performance studies (especially for diagnostics) is not used. The "truth" or benchmark is the predicate device's substantial equivalence in design, materials, and intended use.
The sample size for the training set
- Not applicable / Not provided. No training set, as understood for AI or complex statistical models, is mentioned.
How the ground truth for the training set was established
- Not applicable / Not provided. No training set or ground truth establishment for it is mentioned.

Summary of the Document's Approach to Demonstrating Safety and Effectiveness:

The document leverages the concept of substantial equivalence to a predicate device (K011925 Hypodermic Needle-Pro® Syringe & Needle with Needle Protection Device). Instead of conducting a new study with explicit performance criteria, the manufacturer demonstrates that their proposed device is:

Comprised of identical or similar components and materials as the predicate device.
Has the same intended use (injection of insulin; needle protection after use).
Has similar technical characteristics.
Doesn't raise new questions of safety or effectiveness.

This approach, common for Class II medical devices in 510(k) submissions, assumes that if a new device is sufficiently similar to a previously cleared device, it is also safe and effective. No clinical data, performance studies with acceptance criteria, or expert evaluations for a test set were deemed necessary or were documented in this summary.

Summary

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Image /page/0/Picture/0 description: The image shows a handwritten alphanumeric string. The string is "K014073". The characters are written in black ink on a white background.

Image /page/0/Picture/1 description: The image shows a logo for "PORTEX". The logo consists of a black rectangle with a white, curved shape in the center. The word "PORTEX" is written in black, bold letters inside the white shape. The white shape is curved on the top and bottom.

FEB 1 3 2002

Portex, Inc.

10 Bowman Drive Keene NH 03431-0724 USA Tel: 603 352 3812 www.portexusa.com

K: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

510(K) SUMMARY:

COMPANY INFORMATION:

Portex, Inc. 10 Bowman Drive Keene, NH 03431 (603) 352-3812 Contact: Brian D. Farias Regulatory Affairs Specialist

PREPARATION DATE OF SUMMARY:

December 7, 2001

TRADE NAME:

Hypodermic Needle-Pro® Insulin Syringe & Needle with Needle Protection Device

COMMON NAME:

Insulin Syringe and Needle with attached needle protection

PRODUCT CLASS/CLASSIFICATION:

Class II, 80 FMF, 21 CFR 880.5860 (Piston Syringe)

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PREDICATE DEVICE(S):

K011925 Hypodermic Needle-Pro® Syringe & Needle with Needle Protection Device

DESCRIPTION:

This device is intended for injection of insulin. The needle protection device is an integral I mis device is intended for inforces pre-attached to the needle. Once the needle/needle protection device is attached to a syringe, the collar hoop hinders removal of the needle protection device from the needle. The Needle-Pro® sheath may be adjusted relative to the procedon do roo from are the orange arm to the desired position. After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. As the needle enters the protective sheath, the needle protection device engages and the needle is contained within the sheath. The device should be immediately disposed into a sharps container. The device is supplied with 26G and 27G needles.

INDICATIONS FOR USE:

This device is intended for injection of insulin. The needle protection device covers the needle after use to help prevent needle sticks.

TECHNICAL CHARACTERISTICS:

The proposed device is comprised of identical or similar components and materials as the predicate device. The device is sold sterile.

NON-CLINICAL DATA:

The descriptive characteristics of this device are precise enough to ensure equivalence.

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CLINICAL DATA:

Not applicable

CONCLUSION:

The comparison to the predicate devices demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device.

Very truly yours,

PORTEX, INC.

Brian D. Farias Regulatory Affairs Specialist

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2002

Mr. Brain E. Farias Regulatory Affairs Specialist Portex, Incorporated 10 Bowman Drive Keene, New Hampshire 03431

Re: K014073

Trade/Device Name: Hypodermic Needle-Pro® Insulin Syringe & Needle with Needle Protection Device Regulation Number: 880.5860 Regulation Name: Insulin Syringe and Hypodermic Needle with attached Needle Protection Regulatory Class: II Product Code: FMF Dated: December 7, 2001 Received: December 10, 2001

Dear Mr. Farias:

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 (1 writ), it may of bund 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.

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Page 2 - Mr. Farias

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. of the Act of all - Four and the Act's requirements, including, but not limited to: registration r ou intilet compry wart 807); labeling (21 CFR Part 801); good manufacturing practice and insting (21 es read on the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet form 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 11ths letter will and w you've orgine 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 aller revilla) every 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,

Timotl Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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B: INTENDED USE OF DEVICE

PROPOSED INDICATIONS FOR USE:

Page 1 of 1

510(k) Number (if known): Unknown Kol 4 073

Device Name:

Dories Needle-Pro® Insulin Syringe & Needle with Needle Protection Device

Indications For Use:

This device is intended for injection of insulin. The needle protection device covers the needle after use to help prevent needle sticks.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________ OR Over-The-Counter Use

Petrus Ceccarite

'Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices F 1 (k) Number _______________________________________________________________________________________________________________________________________________________________ 1014073

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).