(86 days)
This device is intended for aspiration and injection of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
The Hypodermic Needle-Pro® Safety Allergy Tray contains 25 graduated hypodermic syringes with permanently affixed needles and integral needle safety sheaths. The safety sheath rotates so it can be adjusted to the desired position relative to the needle bevel and syringe graduations. Each syringe within the tray has a shield over the needle and an end cap covering the end of the plunger. The trav is sterilized using irradiation and the syringe fluid path remains sterile until the shield or end cap is removed. The syringe is used to inject fluids into the body. 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.
This document is a 510(k) Pre-market Notification for the Hypodermic Needle-Pro® Safety Allergy Tray. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria with detailed performance study results against those criteria. Therefore, several requested categories of information are not explicitly present in the provided text.
Here is an attempt to address your request based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Similar Performance Specifications to predicate device | Bench testing confirms that the proposed device and the predicate device have similar performance specifications based on applicable standards for this device and FDA guidance for devices with sharps injury prevention features. |
| Effective Use with needle shielded after use | Simulated clinical use studies confirmed that the device could be used effectively with the needle shielded inside the protection device after use. |
| Safe and Effective | Bench testing and simulated clinical use studies conducted demonstrate that the proposed device is safe and effective. |
| Substantially Equivalent to predicate device | Bench testing and simulated clinical use studies conducted demonstrate that the proposed device is substantially equivalent to the predicate device. |
| Needle protection device covers the needle after use to prevent needle sticks (from Indications for Use) | Confirmed in simulated clinical use studies. |
Explanation of Table: The document explicitly states "similar performance specifications" and "could be used effectively," implying these are the acceptance criteria that were met. The specific quantitative metrics for these "specifications" or "effectiveness" are not enumerated in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench testing" and "Simulated clinical use studies."
- Sample Size: Not specified for either the bench testing or the simulated clinical use studies.
- Data Provenance: Not explicitly stated, but given it's a 510(k) submission from "Smiths Medical ASD, Inc. 10 Bowman Drive Keene NH 03431 USA," the studies were likely conducted in the USA by or for the manufacturer. The studies are by nature prospective as they were specifically conducted to support this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Experts: Not specified.
- Qualifications: Not specified.
The "simulated clinical use studies" would likely involve users (e.g., healthcare professionals) to assess effectiveness, but the quantity and qualifications of these individuals are not detailed in this summary.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Given the nature of a 510(k) for a safety syringe, the "simulated clinical use" likely involved observing successful deployment of the safety mechanism and effectiveness of the device for its intended use, rather than a complex diagnostic ground truth adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study was not done or described in this document. This submission relies on demonstrating substantial equivalence through bench testing and simulated use, not a comparison of human reader performance with and without AI assistance (as this is a physical medical device, not an AI diagnostic tool).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical hypodermic syringe with a safety feature, not an algorithm.
7. The Type of Ground Truth Used
- For Bench Testing: The ground truth would have been established by comparing the device's performance against applicable standards and FDA guidance for devices with sharps injury prevention features, as well as against the performance specifications of the predicate device. This is based on objective, measurable physical properties and functional tests.
- For Simulated Clinical Use Studies: The ground truth was likely based on observational assessment of the device's functional integrity and successful deployment of the safety mechanism according to its design intent. This would involve criteria such as ease of use, successful needle shielding, and effective prevention of needle sticks in a simulated environment.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This document describes a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device submission.
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Image /page/0/Picture/0 description: The image contains the text "KO 72482 Page 1 of 2" at the top. Below that, the word "smiths" is written in a bold, sans-serif font. The text appears to be handwritten and then printed or scanned, as it has a slightly rough or imperfect quality.
Smiths Medical ASD, Inc.
Anesthesia and Safety Devices Division
NOV 2 9 2007
10 Bowman Drive Keene NH 03431 USA Tel: +1 603 352 3812 Fax: +1 603 352 3703 www.smiths-medical.com
st 31, 2007
Product Name:
Trade Name: Hypodermic Needle-Pro® Safety Allergy Tray
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):
K063755 (Smiths Medical ASD, Inc) Portex® Hypodermic Needle-Pro® Fixed Needle TB Syringe
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).
Device Description:
The Hypodermic Needle-Pro® Safety Allergy Tray contains 25 graduated hypodermic syringes with permanently affixed needles and integral needle safety sheaths. The safety sheath rotates so it can be adjusted to the desired position relative to the needle bevel and syringe graduations. Each syringe within the tray has a shield over the needle and an end cap covering the end of the plunger. The trav is sterilized using irradiation and the syringe fluid path remains sterile until the shield or end cap is removed. The syringe is used to inject fluids into the body. 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.
10
. "..".
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: August 31, 2007
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K072482 page 2 of 2
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.
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 with these 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.
BA
Brian D. Farias Regulatory Affairs Manager
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and human aspects. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 9 2007
Mr. Brian D. Farias Regulatory Affairs Manager Smiths Medical ASD, Incorporated 10 Bowman Drive Keene, New Hampshire 03431
Re: K072482
Trade/Device Name: Hypodermic Needle-Pro® Safety Allergy Tray Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: August 31, 2007 Received: September 4, 2007
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 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 Eederal 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.
Sincerely yours,
Chih-Lin, Ph.D.
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 4, Indications for Use Statement
Indications for Use
510(k) Number (if known): Device Name: Hypodermic Needle-Pro® Safety Allergy Tray
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.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (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
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510(k) Number: _ K 972482
§ 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).