(63 days)
The CAREO Retractable Safety Syringe is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection.
The CAREO Retractable Safety Syringe aids in the prevention of needlestick injuries. In addition, when the user breaks the plunger, the CAREO Retractable Safety Syringe reduces the possibility of syringe reuse.
The Life-Shield Products, Inc., CAREO Retractable Safety Syringe is a sterile, single-use and disposable, 3 mL piston syringe, provided with a permanently attached needle in eight product configurations. The CAREO Retractable Safety Syringe is similar in appearance, size, materials, operation, and purpose to the cited predicate device and other conventional single-use, sterile, disposable syringes.
Here's a breakdown of the acceptance criteria and study information for the Life-Shield Products, Inc. CAREO Ret retractable Safety Syringe, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it refers to "specifications" for the simulated use testing. However, it does provide a statement of performance against these implied criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performs according to specification (for simulated use) | "Simulated use testing using 500 syringes demonstrates that the CAREO Retractable Safety Syringe performs according to specification." |
| Equivalence to predicate device (side-by-side testing) | "Side-by-side testing of the CAREO Retractable Safety Syringe and the SECUREGARD® Ret retractable Safety Syringe shows that the two products are equivalent." |
| Biocompatibility | Testing provided in this premarket notification includes biocompatibility. (No specific performance data given, but implies successful testing against relevant standards). |
| Packaging Integrity | Testing provided in this premarket notification includes packaging integrity. (No specific performance data given, but implies successful testing against relevant standards). |
| Standards Conformity | Testing provided in this premarket notification includes standards conformity. (No specific performance data given, but implies successful testing against relevant standards). |
| Supports Claimed Indications for Use (e.g., prevention of needlestick injuries, reduction of syringe reuse) | "Testing also supports the claimed Indications for Use." (No specific quantitative data, but implies successful demonstration of these functionalities through testing). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): 500 syringes were used for the "Simulated use testing."
- Data Provenance: The document states the sponsor is "Life-Shield Products, Inc. 3F, No. 10, Wuchiuan 7th Rd Wugu Shiang Taipei 248 Taiwan, ROC". This suggests the data originates from Taiwan. The study is implicitly prospective as it involves new testing of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish a ground truth for the simulated use testing. The "ground truth" for this type of device likely relies on engineering specifications and direct observation of the device's mechanical function, rather than expert interpretation of data.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned, as the study described is a performance test against specifications, not a comparative study with subjective outcomes.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human interpretation is a key factor. This device is a medical instrument where performance is largely objective and mechanical.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The concept of "standalone" performance (algorithm only) is not applicable here as the device is a physical syringe, not an algorithm or AI. The simulated use testing can be considered a standalone performance assessment of the device itself (without human-in-the-loop in a comparative sense, but of course with a human operating the syringe in the simulation).
7. The Type of Ground Truth Used:
For the "Simulated use testing," the "ground truth" would be the engineering specifications and functional requirements for the syringe. The testing observed whether the syringe performed its intended actions (e.g., needle retraction, plunger breakage) correctly and consistently, as defined by its design specifications. For the "Side-by-side testing," the ground truth was the performance of the predicate device (SECUREGARD® Ret retractable Safety Syringe) against which the CAREO syringe was compared for equivalence.
8. The Sample Size for the Training Set:
The document does not mention a "training set" in the context of device development or testing. This term is typically used in machine learning or AI development. The testing described is for a physical medical device.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" in the context of this device's testing, how its ground truth was established is not applicable.
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510(k) Summary for the Life-Shield Products, Inc. CAREO Retractable Safety Syringe (per 21CFR807.92)
SPONSOR 1.
Life-Shield Products, Inc. 3F, No. 10, Wuchiuan 7th Rd Wugu Shiang Taipei 248 Taiwan, ROC
Contact Person: Mr. Eric Shih, President 011-866-2-2299-6033 Telephone:
Date Prepared: May 13, 2003
2. DEVICE NAME
| Proprietary Name: | CAREO Retractable Safety Syringe |
|---|---|
| Common/Usual Name: | Hypodermic Syringe (with needle) |
| Classification Name: | Piston syringe |
| Hypodermic single lumen needle |
3. PREDICATE DEVICE
- SECUREGARD® Retractable Safety Syringe (K012121) .
4. DEVICE DESCRIPTION
The Life-Shield Products, Inc., CAREO Retractable Safety Syringe is a sterile, single-use and disposable, 3 mL piston syringe, provided with a permanently attached needle in eight product configurations. The CAREO Retractable Safety Syringe is similar in appearance, size, materials, operation, and purpose to the cited predicate device and other conventional single-use, sterile, disposable syringes.
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ડ. INTENDED USE
The CAREO Retractable Safety Syringe is a sterile, single-use, disposable and nonreusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection.
The CAREO Retractable Safety Syringe aids in the prevention of needlestick injuries. In addition, when the user breaks the plunger, the CAREO Retractable Safety Syringe reduces the possibility of syringe reuse.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Life-Shield Products, Inc., makes a claim of substantial equivalence of the CAREO Retractable Safety Syringe to the SECUREGARD® Retractable Safety Syringe (K012121) based on similarities in intended use, design, technological and operational characteristics. Both are indicated for injecting fluids into the body, while helping to reduce the risk of sharps injuries. Both syringes are piston syringes that use permanently attached single lumen hypodermic needles. Both syringes are provided sterile, single-use, and disposable. Both syringes require the user to manually retract the needle-plunger into the syringe barrel, break off the plunger rod, and discard the pieces.
7. TESTING
Testing provided in this premarket notification includes biocompatibility, packaging integrity, standards conformity, and simulated use testing. Side-by-side testing of the CAREO Retractable Safety Syringe and the SECUREGARD® Retractable Safety Syringe shows that the two products are equivalent. Simulated use testing using 500 syringes demonstrates that the CAREO Retractable Safety Syringe performs according to specification. Testing also supports the claimed Indications for Use.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2003
Life-Shield Products, Incorporated C/O Ms. Rosina Robinson, RN, Med, RAC Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K030976
Trade/Device Name: Life-Shield Products, Inc., CAREO Retractable Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: March 27, 2003 Received: March 28, 2003
Dear Ms. Robinson:
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. Robinson:
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 vour 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 vours.
Susa Runnr
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
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510(k) Number (if known):
Device Name: Life-Shield Products, Inc., CAREO Retractable Safety Syringe
Indications for Use:
The CAREO Retractable Safety Syringe is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection.
The CAREO Retractable Safety Syringe aids in the prevention of needlestick injuries. In addition, when the user breaks the plunger, the CAREO Retractable Safety Syringe reduces the possibility of syringe reuse.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pattina Cucente
510(k) Number: K030976
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
CAREO Retractable Safety Syringe Additional Information - K030976
May 13, 2003 Appendix B . Page 1 of 1
§ 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).