The CAREO Safety Syringe for U-100 Insulin is a sterile, single-use, disposable, retractable safety syringe which is intended to provide a safe and reliable method for injection of insulin into a patient.

The CAREO Safety Syringe for U-100 Insulin is also intended to prevent needlestick injuries. In addition, when the user breaks the plunger, reuse of the syringe is prevented.

Device Description

The Life-Shield Products, Inc., CAREO Safety Syringe for U-100 Insulin is a sterile, single use and disposable, 1cc/mL piston syringe, provided with a permanently attached needle in nine product configurations. The CAREO Safety Syringe for U-100 Insulin is similar in appearance, size, materials operation, and purpose to the cited predicate device and other conventional single use, sterile, disposable syringes.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria. Instead, it describes a medical device (CAREO Safety Syringe for U-100 Insulin) and its substantial equivalence to predicate devices. The document explicitly states that "Therefore, no new tests are necessary." because the materials, safety features, and functional/performance characteristics are identical to those already verified and validated for other CAREO Safety Syringes in previous 510(k) premarket notifications.

Therefore, many of the requested fields cannot be filled as the information is not present in the provided text.

Here's an attempt to populate the table and answer the questions based on the available information:

Acceptance Criteria and Device Performance

Since the document states "no new tests are necessary" due to substantial equivalence, specific numerical acceptance criteria for the CAREO Safety Syringe for U-100 Insulin are not presented in this 510(k) submission. The acceptance criteria would likely be implied to be "equivalent to the predicate devices" which have already met their respective criteria.

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance (Implied)
Material Safety	Equivalent to predicate devices (K030976, K052397, K060208)	Verified and Validated (as per predicate device findings)
Biocompatibility	Equivalent to predicate devices (K030976, K052397, K060208)	Verified and Validated (as per predicate device findings)
Safety Feature Functionality (Needlestick Prevention)	Equivalent to predicate devices (K030976, K052397, K060208)	Verified and Validated (as per predicate device findings)
Safety Feature Functionality (Reuse Prevention - Plunger Break)	Equivalent to predicate devices (K030976, K052397, K060208)	Verified and Validated (as per predicate device findings)
Other Functional & Performance Characteristics	Equivalent to predicate devices (K030976, K052397, K060208)	Verified and Validated (as per predicate device findings)

Study Details:

Sample size used for the test set and the data provenance:
- No new test set was used for this specific 510(k) submission because "no new tests are necessary." The device's performance is asserted based on its identical characteristics to previously cleared devices. Data provenance for the original predicate devices' testing is not provided in this document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no new test set was used for this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no new test set was used for this submission.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a manual safety syringe, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual safety syringe, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the predicate devices, the ground truth for performance characteristics would have been established through physical testing (e.g., force required for needle retraction, plunger break functionality, material strength, biocompatibility assays). The specific details are not in this document.
The sample size for the training set:
- Not applicable, as no new training was performed for this 510(k). The basis is substantial equivalence to predicate devices.
How the ground truth for the training set was established:
- Not applicable, as no new training was performed for this 510(k). The basis is substantial equivalence to predicate devices, implying their ground truth was established through standard testing for medical devices of this type.

Summary

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KOLOSS ) of 2

510(k) Premarket Notification

for

JUL I 0 2006

Life-Shield Products, Inc. CAREO Safety Syringe for U-100 Insulin (per 21 CFR807.92)

1. Sponsor

Life-Shield Products, Inc. 3FI., No. 10, Wuchiuan 7th Rd., Wugu Industrial Park, Taipei 248 Taiwan, R.O.C. Contact Person: Mr. Hsiao, Chung-Chih Telephone: +886 2 2299 6033 Fax: +886 2 2299 6035 Date Prepared: April 15, 2006

2. Device Name

Proprietary Name:	CAREO Safety Syringe for U-100 Insulin
Common/Usual Name:	Syringe
Classification Code:	MEG
Classification Name:	Syringe, Antistick

3. Predicate Device

. 1cc Insulin SafePro* Safety Syringe (K050134)
CAREO Safety Syringe 1cc/mL (K060208)

Device Description 4.

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ട. Intended Use

The CAREO Safety Syringe for U-100 Insulin is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for injection of insulin into a patient.

The CAREO Safety Syringe for U-100 Insulin is also intended to prevent needlestick injuries. In addition, when the user breaks the plunger, reuse of the syringe is prevented.

6. Technological Characteristics and Substantial Equivalence

Life-Shield Products, Inc., makes a claim of substantial equivalence of the CAREO Safety Syringe for U-100 Insulin to the 1cc Insulin SafePro* Safety Syringe (K050134) and CAREO Safety Syringe 1cc/mL (K060208) based on similarities in intended use, design, technological and operational characteristics. All are indicated for injecting fluids (insulin) 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, snap off the plunger rod, and discard the pieces.

7. Summary for testing of material and simulated use study

The materials of construction, safety feature, and other functional and performance characteristics of CAREO Safety Syringe for U-100 Insulin are identical to those for the other CAREO Safety Syringes. The material safety test, biocompatibility, and safety feature were already indicated, verified, and validated as shown in the previous 510(k) premarket notifications [K030976, K052397, and K060208]. Therefore, no new tests are necessary.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 0 2006

Mr. Chung-Chih Hsiao Senior Regulatory Affairs Consultant Life-Shield Products, Incorporated 3F1, No. 10, Wuchiuan 7th Road Wugu Industrial Park Taipei 248 TAIWAN R.O.C.

Re: K061055

Trade/Device Name: Life-Shield Products, Inc., CAREO Safety Syringe for U-100 Insulin Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: April 15, 2006 Received: April 17, 2006

Dear Mr. Hsiao:

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. Hsiao

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.

Sincercly yours,

Suite y Michael Oms

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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Kadosss
1.81

510(k) Number (if known):

Device Name : Life-Shield Products, Inc., CAREO Safety Syringe for U-100 Insulin

Indications for Use:

The CAREO Safety Syringe for U-100 Insulin is also intended to prevent needlestick injuries. In addition, when the user breaks the plunger, reuse of the syringe is prevented.

Prescription Use _ (21 CFR 801 Subpart D) OR

Over-The-Counter Use _ X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)

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Life-Shield Products, Inc., Abbreviated 510(k) CAREO Safety Syringe for U-100 Insulin

April 15, 2006

CONFIDENTIAL

Regulation Number and Section

§ 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).