The HookSafe™ U-100 Insulin Syringe; models 0.5cc/ml and 1cc/ml, serves as the vehicle in which medication, insulin can be injected into the human body, via the hypodermic needle injection. The safety mechanism may limit accidental needle stick injuries as well as help to prohibit syringe reuse.

Device Description

The HookSafe™ U-100 Insulin Syringe is the Safety Syringe with the following functional advantage:

Single use, completely non-reusable, all parts and components can be safely discarded.

Fully meets anti-needlestick requirements and incorporates anti-reuse functionality. After the injection of insulin, it is at this stage where the anti-reuse function of our syringe begins, a mechanism within our syringe engages the needle hub and forms a lock. At this point, one simply needs to pull the syringe plunger back and the needle will be completely retracted into the barrel of the syringe. At this stage the syringe becomes completely harmless and fully meets its anti-reuse functionality.

AI/ML Overview

The provided text is a 510(k) summary for the HookSafe™ U-100 Insulin Syringe. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a detailed study with specific acceptance criteria and performance metrics for a new device.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and multi-reader comparative effectiveness studies are not available in the provided document.

Here's an attempt to answer the questions based only on the information provided:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as numerical criteria. The primary "acceptance criteria" presented is substantial equivalence to the predicate device K041970.	The device models 0.5cc/ml and 1cc/ml "maintain the same safety and effectiveness as that of cleared device" (K041970). The device is single-use, non-reusable, fully meets anti-needlestick requirements, and incorporates anti-reuse functionality (needle retraction into the barrel after use).

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, particularly for devices demonstrating substantial equivalence to a predicate, the "acceptance criteria" largely revolve around showing that the new device is as safe and effective as the predicate. This often involves demonstrating compliance with relevant standards and functional equivalence. Explicit quantitative performance metrics are less common in the summary itself, unless the modifications significantly alter performance.

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Available. The document states "verification and validation tests contained in this submission," but does not detail the sample sizes for these tests or their provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Available. This type of information is typically relevant for studies involving diagnostic or interpretive tasks. This submission concerns a physical medical device (syringe) where ground truth would relate to its mechanical function, safety features, and compliance with standards, rather than expert interpretation of data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Available. See above.
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
- No. This is not an AI-assisted diagnostic or interpretive device, so an MRMC study is not relevant or mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implied Functional/Mechanical Performance and Safety Compliance. For a syringe, "ground truth" would likely involve verifying proper mechanical function (e.g., plunger movement, needle retraction), integrity (no leaks), and successful activation of safety features (anti-needlestick and anti-reuse mechanisms) as per engineering specifications and relevant standards. The document states compliance to applicable standards and "verification and validation tests," but does not detail the specific "ground truth" methods used in those tests.
The sample size for the training set
- Not Applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in this context.
How the ground truth for the training set was established
- Not Applicable. See above.

Summary

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510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR IJAN - 9 2007 807.92, and the relevant 510(k) submission guidance.

The assigned 510(k) number is:_ 062318 Submitter's Identifications: Company: BIOTOP TECHNOLOGY CO., LTD. Address: 12 F-2, No. 130, Chung-Hsiao E. Road, Sec.2, Taipei 100, Taiwan, R.O.C. Contact person: Mark Lien

Name of the Device: HookSafe™ U-100 Insulin Syringe, models: 0.5cc/ml and 1cc/ml

1. Information of the 510(k) Cleared device (Predicate device): BIOTOP HookSafe™ Safety Syringe; models 0.5cc/mL, 1cc/mL, 3cc/mL, 5cc/mL, and 10cc/mL (K041970).

3. Device Description:

The HookSafe™ U-100 Insulin Syringe is the Safety Syringe with the following functional advantage:

Single use, completely non-reusable, all parts and components can be safely discarded.

Intended Use:

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5. Comparison to the 510(k) Cleared Device (Predicate Device):

Since the new models HookSafe™ U-100 Insulin Syringe; model 0.5cc/ml and 1cc/ml, were developed from the cleared device HookSafe™ (1cc/ml ) through the design control procedures of BIOTOP TECHNOLOGY CO., LTD. with only the small change in product name and scale graduation, the new device is substantial equivalence to that device being modified, HookSafe™ (1cc/ml ) (K041970).

1. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
  Compliance to the applicable standards is completely identical to that of the device being modified, HookSafe™ (1cc/ml ) (K041970).
1. Conclusions
  The BIOTOP HookSafe™ U-100 Insulin Syringe; model 0.5cc/ml and 1cc/ml have the same intended use and technological characteristics as the cleared device of BIOTOP'S model HookSafe™ (1cc/ml ) (K041970). Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted demonstrate could maintain the same safety and effectiveness as that of cleared device.

In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology 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 consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 9 2007

Ms. Lydia Lee Regulatory Department Leader BIOTOP Technology Company, Limited Chung-Hsiao East Road, Sec. 2 12F-2, No. 130 Taipei, Taiwan 100

Re: K062318

Trade/Device Name: HookSafe™ U-100 Insulin Syringe: Models 0.5cc/ml and 1cc/ml. Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: September 25, 2006 Received: November 29, 2006

Dear Ms. Lee:

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. Lee

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 (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 yours,

Sener Punse

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 (if known):

Device Name: HookSafe™ U-100 Insulin Syringe; models 0.5cc/ml and 1cc/ml.

Indications For Use:

Prescription Use ____________________________________________________________________________________________________________________________________________________________ OR (Part 21 CFR 801 Subpart D)

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)

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In-Off)
ora of Anesthesiology. General Hosp
un Control, Dental Devices

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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).