(70 days)
No
The device description and performance studies focus on mechanical features for needle safety and fluid delivery, with no mention of AI or ML.
No.
Explanation: The device is a syringe intended for aspiration and injection of fluids, which is a method of delivering a therapeutic agent, but not a therapeutic device itself. Its primary function is a delivery mechanism.
No
The device is described as a hypodermic syringe intended for aspiration and injection of fluids, which are therapeutic actions, not diagnostic.
No
The device description clearly describes a physical syringe with a needle and safety sheath, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "aspiration and injection of fluids including Insulin." This describes a device used on the body for delivering or withdrawing substances, not for testing samples outside the body to diagnose conditions.
- Device Description: The description focuses on the physical components of a syringe and needle with a safety feature for injection. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (glucose, antibodies, DNA, etc.)
- Providing diagnostic information about a patient's health status.
The device is clearly a medical device used for administering or withdrawing fluids directly from a patient, which falls under a different regulatory category than IVDs.
N/A
Intended Use / 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.
Portex® Hypodermic Needle-Pro® Fixed Needle TB Syringe: This device is intended for aspiration and injection of fluids. The needle protection device covers the needle after use to help prevent needle sticks.
Portex® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe: 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.
Product codes (comma separated list FDA assigned to the subject device)
MEG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the text "K063755 1 of 2 smiths". The text appears to be handwritten, with the exception of the word "smiths", which is in a bold, sans-serif font. The numbers "K063755" are at the top of the image, followed by "1 of 2" and then "smiths" at the bottom. The image is black and white.
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:
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.
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
1
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
2
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.
3
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
4
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.
5
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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