This device is intended for aspiration and injection of fluids including Insulin. The needle protection device covers the needle after use to help prevent needle sticks.

Device Description

The Portex® Hypodermic Needle-Pro® Fixed Needle Syringe is a graduated hypodermic syringe with a permanently affixed needle and integral needle safety sheath. The safety sheath rotates so it can be adjusted to the desired position relative to the needle bevel and syringe graduations. The syringe is used to inject fluids into the body. The Insulin syringe barrel is graduated in U-100 Insulin units and the TB syringe is graduated in milliliters (ml). After the procedure is completed, the needle is pressed into the sheath using a one-handed technique. The needle enters the protective sheath and is contained within the sheath. The device is then discarded into a sharps container.

AI/ML Overview

The provided text describes a medical device, the "Portex® Hypodermic Needle-Pro® Fixed Needle Syringe," and its regulatory clearance process, including studies conducted to demonstrate its safety and effectiveness. However, it does not contain specific acceptance criteria with numerical targets or detailed study results that would allow for a table of acceptance criteria and reported device performance.

The document highlights the types of studies conducted and their general conclusions, but without specific metrics, it's impossible to fill out the table and provide the granular detail requested for many of the questions.

Here's a breakdown of what can be extracted and what information is missing:

Missing Information:

Specific Acceptance Criteria: The document mentions "similar performance specifications based on the applicable standards," but does not list these standards or their specific benchmarks (e.g., maximum activation force, retention force after activation, sterility assurance levels, leakage rates, etc.).
Quantitative Performance Data: There are no numerical results (e.g., success rates, failure rates, device activation times, force measurements) from the bench testing or simulated clinical use studies.
Sample Sizes (for test set, training set): While "simulated clinical use studies were conducted," the number of participants or simulated uses is not provided. The term "bench testing" implies a set of tests, but not the quantity of devices used.
Data Provenance (country of origin, retrospective/prospective): Not specified.
Number and Qualifications of Experts for Ground Truth: Not mentioned, as the studies are focused on device function and safety features, not expert interpretation of diagnostic images or outcomes.
Adjudication Method: Not applicable given the nature of the device and studies described.
MRMC Comparative Effectiveness Study: Not conducted, as this is for diagnostic algorithms, not mechanical devices.
Standalone (algorithm only) Performance: Not applicable, as this is a physical medical device, not an algorithm.
Type of Ground Truth: The "ground truth" here is the functionality of the device (e.g., successful needle shielding, fluid delivery) as measured in bench tests and simulated use. It's not a diagnostic ground truth (like pathology or outcomes data).
How Ground Truth for Training Set was Established: Not applicable as there's no "training set" in the context of an algorithm. For a physical device, development and internal testing (analogous to "training") would precede the formal validation studies, but specific ground truth establishment for this phase isn't detailed here beyond general "bench testing."

Based on the provided text, here is what can be inferred or stated:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from text)	Reported Device Performance (Inferred from text)
Safety Features:
1a. Needle Protection: Device covers the needle after use to help prevent needle sticks.	Confirmed effective; "the device could be used effectively with the needle shielded inside the protection device after use."
Performance Specifications (General):
2a. Similar performance to predicate device based on applicable standards.	Bench testing confirms "similar performance specifications" to the predicate device.
Functionality:
3a. Aspiration and Injection of Fluids: Ability to aspirate and inject fluids (including U-100 Insulin for insulin syringe).	Implied to be met, as the overall conclusion states the device is "safe and effective."
Usability:
4a. Effective Use (Simulated Clinical): Device can be used effectively in simulated clinical scenarios.	Confirmed effective; "Simulated clinical use studies were conducted for Insulin and TB syringes which confirmed that the device could be used effectively."
Overall:
5a. Safe and Effective: Device is safe and effective for its intended use.	Conclusion: "The bench testing and simulated clinical use studies conducted demonstrate that the proposed device is safe and effective..."
5b. Substantial Equivalence: Device is substantially equivalent to the predicate device.	Conclusion: "...and is substantially equivalent to the predicate device."

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified. The document states "Simulated clinical use studies were conducted," but does not give the number of trials or devices tested. Similarly, "Bench testing confirms..." does not include sample size.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). However, the studies were conducted by Smiths Medical ASD, Inc., a U.S. company with a facility in Keene, NH, USA. The nature of these studies ("bench testing," "simulated clinical use") implies prospective testing for the purpose of this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not specified. The studies described are focused on the mechanical and functional performance of a physical device (e.g., needle shielding, fluid delivery), not on diagnostic interpretation or expert consensus on clinical findings. Therefore, no "ground truth" experts in the typical sense (e.g., radiologists) would be used for this type of validation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers on diagnostic tasks, which is not the nature of these studies.

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:

No. An MRMC comparative effectiveness study is used to evaluate the impact of AI on human diagnostic performance. This device is a physical medical instrument (syringe with safety features), not an AI algorithm, so such a study was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This question applies to algorithms. The studies described are for a physical device, demonstrating its functionality and safety features.

7. The type of ground truth used:

The "ground truth" for these studies is the direct functional performance and safety demonstration of the device as measured in:
- Bench testing: Verifying "performance specifications" against applicable standards and comparison to the predicate device. This would involve objective measurements (e.g., force, dimensions, leakage, activation success).
- Simulated clinical use studies: Demonstrating that the "device could be used effectively with the needle shielded inside the protection device after use." This would involve observing successful activation of the safety mechanism and proper use of the syringe.

8. The sample size for the training set:

Not applicable/Not specified. This question typically refers to the data used to train an AI algorithm. For a physical device, there isn't a "training set" in this sense. Device development would involve design, prototyping, and internal testing, which might be considered analogous to iterative "training," but specific data sets labeled as "training sets" are not mentioned.

9. How the ground truth for the training set was established:

Not applicable due to the nature of the device (physical medical instrument, not an AI algorithm). Ground truth for early-stage development of a physical device would be based on engineering specifications, regulatory guidelines, and internal quality control measurements.

Summary

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FEB 2 7 2007

SECTION 5, 510(k) Summary

Company Information:

Smiths Medical ASD, Inc. 10 Bowman Drive Keene, NH 03431 (603) 352-3812, prompt 4, ext 2493 Contact: Brian D. Farias Regulatory Affairs Manager

Summary Prepared: December 18, 2006

Product Name:

Trade Name: Portex® Hypodermic Needle-Pro® Fixed Needle Syringe

Common Name: Fixed Needle Hypodermic Syringe with attached needle protection

Classification Name: 880.5860 Piston Syringe with Single Lumen Needle with antistick

Predicate Device(s):

K024249 (Terumo Medical Corporation) Terumo SurGuard™ Insulin, Allergy and General Use Safety Syringe and alternate brand name Portex "Hypodermic Needle-Pro® Fixed Needle Syringe (referred to as the "Terumo SurGuard™ Safety Syringe" throughout the remainder of this submission).

Please note that the attached needle protection (brand name Needle-Pro®) of the predicate device is supplied to Terumo Medical Corporation by Smiths Medical holds a 510(k) for this device, K011925. The needle protection component of the proposed device is essentially the same as that cleared above except it is made from a different polypropylene.

Device Description:

Smiths Medical ASD, Inc.

Anesthesia and Safety Devices Division

10 Bowman Drive Keene NH 03431 USA Tel: +1 603 352 3812 Fax: +1 603 352 3703 www.smiths-medical.com

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Kc 63755-
2 of 2

Indications for Use:

This device is intended for aspiration and injection of fluids including Insulin. The needle protection device covers the needle after use to help prevent needle sticks. [See pages 9 and 10 for the specific indication for Insulin and TB (General Use) syringes)

Technological Characteristics:

The proposed and predicate devices have a permanently affixed needle and a hinged style protective sheath that is manually activated after use.

Non-Clinical Data:

Bench testing confirms that the proposed device and the predicate device have similar performance specifications based on the applicable standards for this device and FDA guidance for devices with sharps injury prevention features.

Clinical Data:

Simulated clinical use studies were conducted for Insulin and TB syringes which confirmed that the device could be used effectively with the needle shielded inside the protection device after use.

Conclusion:

The bench testing and simulated clinical use studies conducted demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate device.

Very truly yours,

SMITHS MEDICAL ASD, INC.

Brian D. Farias Regulatory Affairs Manager

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S.A." is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Brian D. Farias Regulatory Affairs Manager Smiths Medical ASD, Incorporated 10 Bowman Drive Keene, New Hampshire 03431

FEB 2 7 2007

Re: K063755

Trade/Device Name: Portex® Hypodermic Needle-Pro® Fixed Needle TB Syringe, Portex® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Il Product Code: MEG Dated: December 18, 2006 Received: December 19, 2006

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 cither 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.

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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. 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 (240) 276-0115. 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/cdrh/industry/support/index.html.

く

Sincerely yours,

Susan Purnas

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4B, Indications for Use Statement

Indications for Use

510(k) Number (if known):	K063755
Device Name:	Portex® Hypodermic Needle-Pro® Fixed Needle TB Syringe

Indications for Use:

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

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

c. Intyre U.M.

K463755

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SECTION 4A, Indications for Use Statement

Indications for Use

510(k) Number (if known):	K063755
Device Name:	Portex® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe

Indications for Use:

This device is intended for aspiration and injection of U-100 Insulin Only. The needle protection device covers the needle after use to help prevent needle sticks.

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page _1 of 1 _

Clm 2

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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).