(113 days)
The CAREO 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 Safety Syringe aids in the prevention of needlestick injuries. In addition, when the user breaks the plunger, the CAREO Safety Syringe reduces the possibility of syringe reuse.
The Life-Shield Products, Inc., CAREO Safety Syringe is a sterile, single use and disposable, 3, 5, 10 mL piston syringe, provided with a permanently attached needle in twelve product configurations. The CAREO Safety Syringe is similar in appearance, size, materials, operation, and purpose to the cited predicate device and other conventional single use, sterile, disposable syringes.
The provided 510(k) summary for the CAREO Safety Syringe describes several aspects of the device and its testing but does not explicitly state specific acceptance criteria or an overarching study designed to prove the device meets those criteria in the typical format of a clinical trial for AI/software devices. This document is from 2005, predating the widespread use and regulatory frameworks for AI-driven medical devices.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various tests and conformity to standards.
Here's an attempt to extract and interpret the information based on the provided text, acknowledging that many requested fields may not be directly applicable or explicitly stated in this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit numerical acceptance criteria for performance metrics are not stated in the provided document, we infer them from the nature of the tests conducted and the claim of substantial equivalence. The "reported device performance" is a general statement about meeting specifications rather than specific metrics.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Physiochemical Compatibility (Equivalent to predicates) | CAREO Safety Syringe, SafePro*, SECUREGARD®, and CAREO Retractable Safety Syringe are equivalent. |
| Biocompatibility (As per applicable standards) | Device meets biocompatibility requirements (implied by "biocompatibility testing"). |
| Standard Conformity (Meets applicable medical device standards) | Device conforms to relevant standards (implied by "standard conformity testing"). |
| Simulated Use Performance (Performs according to specification) | Simulated use testing has demonstrated that the CAREO Safety Syringe performs according to specification. |
| Indications for Use Support (Testing supports claimed indications) | Testing supports the claimed Indications for Use, including prevention of needlestick injuries and reduction of syringe reuse. |
| Substantial Equivalence (Similar intended use, design, technological/operational characteristics to predicates) | Demonstrated substantial equivalence to SafePro* (K012726), SECUREGARD® (K012121), and CAREO Retractable Safety Syringe (K030976) based on similarities in intended use, design, technological and operational characteristics. |
| Sterility (Provided sterile) | Syringe is provided sterile, single-use, and disposable. |
| Prevention of Needlestick Injuries (Aids in prevention) | Aids in the prevention of needlestick injuries. |
| Reduction of Syringe Reuse (Reduces possibility when plunger is broken) | Reduces the possibility of syringe reuse when the user breaks the plunger. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for any of the described tests (physiochemical, biocompatibility, standard conformity, simulated use). It only mentions "Testing provided in this premarket notification includes..." The data provenance (country of origin, retrospective/prospective) is also not specified for these tests. Given the nature of a 510(k) for a physical medical device like a syringe, these tests would typically be laboratory or bench tests rather than clinical studies with human patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This concept is not relevant or applicable to the type of device (a safety syringe) and the testing described in this 510(k) submission. "Ground truth" established by experts is typically associated with diagnostic AI/imaging devices.
4. Adjudication Method for the Test Set
Not applicable. The tests described are laboratory/bench tests, not clinical studies requiring expert adjudication methods like 2+1 or 3+1.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is specifically for evaluating the effectiveness of AI with human readers, typically in image interpretation. The device is a physical safety syringe, not an AI or imaging device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, this is not an AI or software algorithm. The "performance" relates to the physical and functional aspects of the syringe itself.
7. Type of Ground Truth Used
The "ground truth" for the tests mentioned (physiochemical, biocompatibility, standard conformity, simulated use) would be based on:
- Scientific principles and material properties for physiochemical compatibility.
- Established biological safety standards for biocompatibility.
- Recognized industry standards (e.g., ISO for medical devices) for standard conformity.
- Pre-defined performance specifications for simulated use testing.
It is not based on expert consensus, pathology, or outcomes data in a clinical sense for this device.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this physical device.
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DEC 2 2 2005
510(k) Summary for the Life-Shield Products, Inc. CAREO Safety Syringe (per 21CFR807.92)
SPONSOR !.
Life-Shield Products, Inc. 3F, No. 10, Wuchiuan 7th Rd Wugu Industrial Park Taipei, Taiwan 248 ROC
Contact Person: Mr. Kurt Lo, Vice President 011-866-2-2299-6033 Telephone:
Date Prepared: May 30, 2005
DEVICE NAME 2.
| Proprietary Name: | CAREO Safety Syringe |
|---|---|
| Common/Usual Name: | Hypodermic Syringe (with needle) |
| Classification Name: | Piston syringe |
| Hypodermic single lumen needle |
PREDICATE DEVICE 3.
- SafePro* Safety Syringe (K012726) .
- SECUREGARD® Retractable Safety Syringe (K012121) .
- CAREO Retractable Safety Syringe (K030976) .
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DEVICE DESCRIPTION 4.
The Life-Shield Products, Inc., CAREO Safety Syringe is a sterile, single use and disposable, 3, 5, 10 mL piston syringe, provided with a permanently attached needle in twelve product configurations. The CAREO Safety Syringe is similar in appearance, size, materials, operation, and purpose to the cited predicate device and other conventional single use, sterile, disposable syringes.
5. INTENDED USE
The CAREO 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 Safety Syringe aids in the prevention of needlestick injuries. In addition, when the user breaks the plunger, the CAREO Safety Syringe reduces the possibility of syringe reuse.
SUBSTANTIAL CHARACTERISTICS AND AND AND 6. TECHNOLOGICAL EQUIVALENCE
Life-Shield Products, Inc., makes a claim of substantial equivalence of the CAREO Safety Syringe to the SafePro* Safety Syringe (K012726), SECUREGARD® Retractable Safety Syringe (K012121) and CAREO Retractable Safety Syringe (K030976) based on similarities in intended use, design, technological and operational characteristics. All three are indicated for injecting fluids into the body, while helping to reduce the risk of sharps injuries. All syringes are piston syringes that use permanently attached single lumen hypodermic needles. All syringes are provided sterile, single-use, and disposable. All syringes require the user to manually retract the needle-plunger into the syringe barrel, break off the plunger rod, and discard the pieces.
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1052397 3 83
TESTING 7.
Testing provided in this premarket notification includes physiochcmical Side-by-side compatibility, biocompatibility, and standard conformity. CAREO Safety Syringe, SafePro* Safety Safety Syringe, of comparison SECUREGARD® Retractable Safety Syringe and the CAREO Retractable Safety Syringe shows that three products are equivalent. Simulated use testing has demonstrated that the CAREO Safety Syringe performs according to specification. Testing also supports the claimed Indications for Use.
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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular arrangement of text around an emblem. The emblem is a stylized design of three overlapping human figures, possibly representing health, family, and community. The text is "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 2005
Dr. Jen, Ke-Min Consultant Life-Shield Products, Incorporated 3F, No.10, Wuchiuan 7th Road Wugu Industrial Park Taipei, 248, Taiwan
Re: K052397
R032397
Trade/Device Name: CAREO Safety Syringe (3cc/mL, 5cc/mL, 10cc/mL) Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: December 2, 2005 Received: December 8, 2005
Dear Dr. Ke-Min:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use stated in the enactment date of the Medical Device interstate colliments, or to triay 20, 1978, and same with the provisions of Amendments, of to devices that nave been formselves approval of a prematice the fleaths the fleast of the Federal Food, Drug, and Oosmene 110 (710) -------------------------------------------------------------------------------------------------------------------------------approval application (1 MrY). Fou Fray, crow sions of the Act include controls provisions of the Fet. "The genting of devices, good manufacturing practice, requirements for and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III if your device is Classified (sec above) into enner cos. Existing major regulations affecting (PMA), it may be subject to such adultions, Title 21, Parts 800 to 899. In
your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Code of Peacharies.
addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Dr. Ke-Min
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advisod that 1 DTC s loodines of about of the complies with other requirements mean that iDA nas made a decemind regulations administered by other Federal agencies. of the Act of any I oderal barates and squirements, including, but not limited to: registration You must comply with an the Hec Fee s reg (21 CFR Part 801); good manufacturing practice and and ilsting (21 CFR Part 807), labeling (21 cm (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) I mis letter will anow you to begal mading of substantial equivalence of your device to a premiarket notification. The PDF Intelligence can also 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), II you desire specific advice for your see at (240) 276-0115. Also, please note the regulation in prease contact the Other or Sommerces to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may outain other general mironial and Consumer Assistance at its toll-free Division of Binas-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sylvette Y. Michaud, DmX
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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Indications for Use
510(k) Number:
Device Name:
LIFE-SHIELD Products, Inc. CAREO Safety Syringe (3cc/mL, 5cc/mL, 10cc/mL)
INTENDED USE
The CAREO 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 Safety Syringe aids in the prevention of needlestick injuries. In additional, when the user breaks the plunger, the CAREO Safety Syringe reduces the possibility of syringe reuse.
Prescription Use _ V (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)
Shuli H. Maugher D/MCB/6 HON 12/22/65
K 052397
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§ 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).