(27 days)
NotFound
No
The device description and intended use clearly define a manual syringe with a fixed needle, with no mention of any computational or analytical capabilities that would involve AI/ML.
No
The device is an insulin syringe, used for injecting fluids (specifically insulin) into the body, but it does not inherently provide a therapeutic effect itself; it is a delivery mechanism for a therapeutic substance.
No
This device is described as an insulin syringe for fluid aspiration and injection, with no mention of diagnostic capabilities or the collection of diagnostic data.
No
The device description clearly states it is a sterile, single use piston syringe with a fixed hypodermic single lumen needle, which are physical hardware components.
Based on the provided information, the TERUMO® 31G ThinPro™ Insulin Syringe is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the manual aspiration and injection of fluids into parts of the body below the surface of the skin, specifically insulin. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically in a lab setting).
- Device Description: The description details a syringe and needle for injecting substances into the body. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This syringe is used to administer a substance into the body.
N/A
Intended Use / Indications for Use
The TERUMO® 31G ThinPro™ Insulin Syringe, with fixed hypodermic single lumen needle, is a device intended for medical purposes for the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. This device is intended particularly for the aspiration and injection of insulin. This syringe with 31G needle is indicated for general use and for pediatric patients.
Product codes
FMF
Device Description
The TERUMO® 31G ThinPro™ Insulin Syringe is a sterile, single use piston syringe with a fixed hypodermic single lumen needle, designed for manual use. The syringe is available in 3/10 cc, 1/2 cc, and 1 cc volumes with a 31 gauge by 3/8 inch fixed hypodermic single lumen needle. Each syringe includes unit markings (3/10 cc = 1/2 unit markings, 1/2 cc = single unit markings, and 1 cc = two unit markings).
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
general use and for pediatric patients.
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)
The performance of this device is equivalent to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K822083, K992802, K001474, K955235
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K07/630
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SUMMARY
TERUMO® 31G ThinPro™ Insulin Syringe Device Name:
Classification Name: Piston syringe with fixed hypodermic single lumen needle
INTENDED USE
The TERUMO® 31G ThinPro™ Insulin Syringe, with fixed hypodermic single lumen needle, is a device intended for medical purposes for the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. This device is intended particularly for the aspiration and injection of insulin. This syringe with 31G needle is indicated for general use and for pediatric patients. The pediatric indication is cleared for the Terumo 30G Insulin Syringe (K001474 - Pediatric Indication).
DESCRIPTION
The TERUMO® 31G ThinPro™ Insulin Syringe is a sterile, single use piston syringe with a fixed hypodermic single lumen needle, designed for manual use. The syringe is available in 3/10 cc, 1/2 cc, and 1 cc volumes with a 31 gauge by 3/8 inch fixed hypodermic single lumen needle. Each syringe includes unit markings (3/10 cc = 1/2 unit markings, 1/2 cc = single unit markings, and 1 cc = two unit markings).
SUBSTANTIAL EQUIVALENCE
The TERUMO® 31G ThinPro™ Insulin Syringe submitted in this 510k is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared TERUMO® Insulin Syringe (K822083, K992802, & K001474 - Pediatric Indication) and the Becton Dickinson® Ultra-Fine™ II Insulin Syringe (K955235).
PRINCIPLE OF OPERATION/TECHNOLOGY
This device is operated manually.
MATERIALS
The materials used in this device are the same as used in the TERUMO® Insulin Syringe (K822083, K992802, & K001474 - Pediatric Indication).
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PERFORMANCE
The performance of this device is equivalent to the predicates.
CONCLUSION
The TERUMO® 31G ThinPro™ Insulin Syringe submitted in this Premarket notification is substantially equivalent to the TERUMO ® Insulin Syringe (K822083, K992802, & K001474 - Pediatric Indication) and Becton Dickinson® Ultra-Fine™ II Insulin Syringe (K955235) with respect to intended use, design, technology/principles of operation, and performance. Differences between the devices do not raise any new issues of safety or effectiveness.
Date Prepared: 6/12/2007 Prepared by: Eileen Dorsey Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Blvd. Elkton, MD 21921 Phone: (410) 392-7241 Fax: (410) 398-6079 Email: eileen.dorsey@terumomedical.com
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like emblem with three curved strokes, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the emblem. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Eileen Dorsey Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard Elkton, Maryland 21921
JUL 1 1 2007
Re: K071630
Trade/Device Name: TERUMO® 31G ThinPro Insulin Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: June 12, 2007 Received: June 14, 2007
Dear Ms. Dorsey:
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 Federal Register.
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Page 2 -- Ms. Dorscy
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Carls
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
Indications for Use
| 510(k) Number (if known) | K67 1630 |
|---|---|
| -------------------------- | ---------- |
Device Name: _
Indications For Use:
The TERUMO® 31G ThinPro Insulin Syringe, with fixed hypodermic single lumen needle, is a device intended for medical purposes for the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. This device is intended particularly for the aspiration and injection of insulin. This syringe with 31G needle is indicated for general use and for pediatric patients.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
7/4/07
on Sign-Off) ivision of Anesthesiology, General Hospital, Infection Control, Dental Devi
510(k) Number: K071638
000099