(91 days)
Not Found
No
The summary describes a mechanical syringe with a needle retraction mechanism. There is no mention of any computational analysis, algorithms, or learning processes.
No.
The device is a syringe used for fluid aspiration and injections, primarily designed for safe delivery of medication or removal of fluids, and prevention of needle stick injuries, rather than for directly treating a disease or condition.
No
Explanation: The device is a syringe used for fluid aspiration and injection, not for diagnosing medical conditions.
No
The device description clearly outlines a physical syringe with a needle and a needle protection system, indicating it is a hardware medical device.
Based on the provided information, the BD Integra™ Syringe is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin." This describes a device used for administering substances into the body or withdrawing substances from containers, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on the physical characteristics of a syringe and needle, including a safety mechanism for needle retraction. This aligns with a device used for injections and aspirations.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue), detect markers, or provide diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The BD Integra™ Syringe's function is purely for the delivery or withdrawal of fluids.
N/A
Intended Use / Indications for Use
The BD Integra™ Syringe is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin. It is not intended to be used for phlebotomy. The insulin syringe has scale lines in insulin units and is used for insulin injections. The tuberculin syringe can be used for any of the 3 types of common injections (intra-dermal, intra-muscular or subcutaneous).
The BD Integra™ 1ml Syringe has a permanently attached needle. The BD Integra™ 1ml Syringe contains a tool used to cut through the hub and stopper allowing the needle to become retracted inside the plunger rod of the syringe after use. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
Product codes
MEG, FMF
Device Description
Single-use syringe with a needle protection system. Needle sizes: 30G-25G, Syringe sizes: 1ml.
The BD Integra™ Iml Syringe has a permanently attached needle. The BD Integra™ Iml Syringe contains a tool used to cut through the hub and stopper allowing the needle to become retracted inside the plunger rod of the syringe after use. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
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)
The BD Integra™ Syringes performed in a similar manner to the predicate devices based on comparisons using the following criteria: shield removal, cannula removal, stopper breakout and sustaining force, hub and stopper leakage, dead space, activation forces, hub/barrel separation forces, cannula containment and splatter.
A Simulated Use Study was performed on the BD Integra™ 1ml Syringe. The BD Integra™ 1 ml Syringe performed equivalently to the BD conventional insulin and tuberculin syringes with respect to the following characteristics: Overall performance, Ease of maintaining standard injection technique, Ability to maintain aseptic technique, Ability to aspirate medication from a vial, Ability to read the syringe scale on the barrel, Ability to passively re-shield and transport, Ability to easily and safely dispose of the used device in a sharps container, Perceived safety of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
1 Becton Drive Franklin Lakes, New Jersey 07417 tel: 201.847.6800 www.bd.com
Attachment 5
REVISED
Summary of Safety & Effectiveness for the BD Integra™ 1ml Syringe
1. BD Contact Person:
Pasquale Amato Regulatory Affairs Coordinator BD Medical Surgical BD 1 Becton Drive MC226 Franklin Lakes, NJ Phone: 201-847-4513 Fax: 201-847-4855 E-mail: pasquale amato@bd.com
FEB 07 2003
-
- Device Name: BD Integra™ 1ml Syringe
4. Product Description/Function:
4.1 Description: Single-use syringe with a needle protection system. Needle sizes: 30G-25G, Syringe sizes: 1ml.
-
- Intended uses: The BD Integra™ Syringe is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin. It is not intended to be used for phlebotomy. The insulin syringe has scale lines in insulin units and is used for insulin injections. The tuberculin syringe can be used for any of the 3 types of common injections (intra-dermal, intra-muscular or subcutaneous).
The BD Integra™ Iml Syringe has a permanently attached needle. The BD Integra™ Iml Syringe contains a tool used to cut through the hub and stopper allowing the needle to become retracted inside the plunger rod of the syringe after use. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
- Intended uses: The BD Integra™ Syringe is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin. It is not intended to be used for phlebotomy. The insulin syringe has scale lines in insulin units and is used for insulin injections. The tuberculin syringe can be used for any of the 3 types of common injections (intra-dermal, intra-muscular or subcutaneous).
1
6. Comparison of Modified & Predicate Devices:
6.1 Descriptive Comparison to a Legally Marketed Device The BD Integra™ Syringes can be used in the same fashion as standard BD Insulin/Tuberculin syringes. When the BD Integra™ Syringe is in the "ready-to-use" position it provides the same usable injection needle length and same barrel scale markings as a standard insulin / tuberculin syringes.
Comparison has been made to the BD insulin/tuberculin Syringe. The BD Integra™ Syringe is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin. It is not intended to be used for phlebotomy.
The BD Integra™ Syringe contains a tool used to cut through the stopper and hub allowing the needle to become retracted inside the plunger rod of the syringe after use. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
6.2 Material Changes: There are no significant changes in the materials used for the BD Integra™ Syringe
6.3 Manufacturing Process Changes: The manufacturing processes are being modified to assemble the components associated with the BD Integra™ Syringe.
6.4 Manufacturing Site Changes: No new manufacturing site is being utilized.
6.5 Packaging Component Changes: The package design is being modified to accept the size of the BD Integra™ Syringe.
7. Equivalence determination:
The BD Integra™ Syringe was compared to the predicate devices using the following criteria: shield removal, cannula removal, stopper breakout and sustaining force, hub and stopper leakage, dead space, activation forces, hub/barrel separation forces, cannula containment and splatter. The BD Integra™ Syringes performed in a similar manner to the predicate devices.
A Simulated Use Study was performed on the BD Integra™ 1ml Syringe. The BD Integra™ 1 ml Syringe performed equivalently to the BD conventional insulin and tuberculin syringes with respect to the following characteristics:
Overall performance
- . Ease of maintaining standard injection technique
- Ability to maintain aseptic technique ●
- Ability to aspirate medication from a vial ●
- Ability to read the syringe scale on the barrel
- Ability to passively re-shield and transport
- Ability to easily and safely dispose of the used device in a sharps container
- Perceived safety of the device .
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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 depiction of a bird or eagle with three curved lines representing its wings or feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 7 2003
BD
Mr. Pasquale Amato Regulatory Affairs Coordinator BD Medical Surgical 1 Becton Drive MC226 Franklin Lakes, New Jersey 07417
Re: K023752
Trade/Device Name: BD Integra™ 1 ml Syringe Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG, FMF Dated: January 16, 2003 Received: January 17, 2003
Dear Ms. Amato:
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 vour 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. Amato
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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours,
Susan O'Kunner
Susan Runner, DDS, MA Interim 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 Statement
510(k) Number (if known): K023752
Device Name: BD Integra™ 1 ml Syringe
Indications for Use:
The BD Integra™ Syringe is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin. It is not intended to be used for phlebotomy. The insulin syringe has scale lines in insulin units and is used for insulin injections. The tuberculin syringe can be used for any of the 3 types of common injections (intra-dermal, intra-muscular or subcutaneous).
The BD Integra™ 1ml Syringe has a permanently attached needle. The BD Integra™ 1ml Syringe contains a tool used to cut through the hub and stopper allowing the needle to become retracted inside the plunger rod of the syringe after use. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use |
|---|
| (Per 21 CFR 801.109) |
Over-The-Counter Use
Patricia Lucente
(Division Sign-Off)
OR
sthesiology, General Hospital