BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML by BIOTOP TECHNOLOGY CO., LTD.

The BIOTOP HookSafe™ LUER-LOCK Safety Syringe; models 3cc/mL, and 10cc/mL serves as the vehicle in which medication can be injected into the human body, or fluid withdrawn from the human body, via the hypodermic needle injection.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™ LUER-LOCK series is the Safety Syringe with the following functional advantage: Single use, completely non-reusable, all parts and components can be safely inoperative and safely discarded. Fully meets anti-needlestick requirements and incorporates anti-reuse functionality as well. As with any normal syringe, after the injection process, the syringe plunger should be fully depressed to ensure complete injection of the serum. It is at this stage where the anti-reuse function of our syringe begins; a mechanism within our syringe engages the syringe needle and forms a lock. At this point, one simply needs to pull the syringe plunger back again and the needle will be completely retracted into the barrel of the syringe. Because the needle, when retracted, is in a stably-tilted position and forced against the inner shoulder of the syringe barrel. At this stage the syringe becomes completely harmless and fully meets its anti-reuse functionality.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria and the results of a study designed to prove a device meets those criteria. Instead, it describes a 510(k) submission for the BIOTOP HookSafe™ LUER-LOCK Safety Syringe, focused on demonstrating substantial equivalence to a previously cleared predicate device.

The document highlights the following:

No explicit acceptance criteria for "performance" beyond substantial equivalence: The core claim is that the new models are substantially equivalent to the predicate device despite a "small change in the needle change mechanism." The "discussion of non-clinical tests" simply states "Compliance to the applicable standards is completely identical to that of the device being modified." This suggests that the acceptance criteria for the new device are implicitly the same as those met by the predicate device, and the current submission relies on the predicate's established performance.
"Verification and validation tests" are mentioned but not detailed: The text states, "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." However, no specifics about these tests (e.g., protocols, sample sizes, failure rates, or specific performance metrics) are provided.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's a breakdown of what can be inferred or determined from the text, and what critically cannot:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (Not explicitly stated for this device)
Safety:
Limit accidental needle stick injuries (functional)	Demonstrated to maintain safety equivalent to predicate device.
Prohibit syringe reuse (functional)	Demonstrated to maintain effectiveness equivalent to predicate device.
Effectiveness:
Enable medication injection/fluid withdrawal (functional)	Demonstrated to maintain effectiveness equivalent to predicate device.
Compliance to applicable standards (not specified here)	"Compliance to the applicable standards is completely identical to that of the device being modified." (K041970)

Missing Information for Table: Specific quantitative acceptance criteria (e.g., "Needle stick injury rate < 0.1%", "Reuse prevention rate = 100%"). The document only states the device may limit accidental needle stick injuries and help to prohibit syringe reuse, which are qualitative statements of intended function, not quantitative acceptance criteria.

2. Sample size used for the test set and the data provenance:

Sample size: Not specified. The document mentions "verification and validation tests" but not the number of units tested.
Data provenance: Not specified. Given the company is in Taiwan, some testing may have occurred there, but this is not confirmed. It's a 510(k) submission, not a clinical trial report, so the focus is often on engineering testing rather than clinical data provenance in this context. There's no mention of retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as the provided text doesn't describe a study involving expert-established ground truth on a test set (e.g., for diagnostic accuracy). The testing described is for the functional and safety aspects of the device itself (e.g., anti-needlestick, anti-reuse).

4. Adjudication method for the test set:

Not applicable. (See answer above for #3).

5. 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 is a syringe, not an AI-powered diagnostic device, so MRMC studies are irrelevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a syringe, not an algorithm.

7. The type of ground truth used:

For the functional and safety aspects of the syringe, the "ground truth" would likely be engineering specifications, compliance with relevant ISO standards for medical devices (e.g., for syringe dimensions, fluid leakage, needle retention, etc.), and successful activation of the safety mechanism. The text states "Compliance to the applicable standards is completely identical to that of the device being modified," indicating adherence to known industry standards.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device requiring a training set.

9. How the ground truth for the training set was established:

Not applicable. (See answer above for #8).

In summary, the provided document is a 510(k) summary focused on establishing substantial equivalence for a medical device (a safety syringe) based on engineering changes. It does not provide the kind of detailed study results, acceptance criteria, or ground truth establishment methods that would be relevant for a diagnostic device or an AI/ML-powered system. The "study" mentioned is general "verification and validation tests" to ensure the minor design change did not negatively impact safety and effectiveness compared to the predicate device.

Summary

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BIOTOP TECHNOLOGY CO., LTD.

510(K) SUMMARY

K04 3038
172

DEC 2 2 2004

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

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________ 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

1. Name of the Device: BIOTOP HookSafe™ LUER-LOCK Safety Syringe; models 3cc/mL, 5cc/mL, and 10cc/mL.
1. Information of the 510(k) Cleared Device (Predicate Device): BIOTOP HookSafe™ Safety Syringe, models 3cc/mL, and 10cc/mL (K041970).
1. Device Description:
- The HookSafe™ LUER-LOCK series is the Safety Syringe with the following functional advantage: Single use, completely non-reusable, all parts and components can be safely inoperative and safely discarded.
- Fully meets anti-needlestick requirements and incorporates anti-reuse functionality as well. As with any normal syringe, after the injection process, the syringe plunger should be fully depressed to ensure complete injection of the serum. It is at this stage where the anti-reuse function of our syringe begins; a mechanism within our syringe engages the syringe needle and forms a lock. At this point, one simply needs to pull the syringe plunger back again and the needle will be completely retracted into the barrel of the syringe. Because the needle, when retracted, is in a stably-tilted position and forced against the inner shoulder of the syringe barrel. At this stage the syringe becomes completely harmless and fully meets its anti-reuse functionality.
1. Intended Use:

The BIOTOP HookSafe™ LUER-LOCK Safety Syringe; models: 3cc/mL, and 10cc/mL serves as the vehicle in which medication can be injected into the human body, or fluid withdrawn from 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.

1. Comparison to the 510(k) Cleared Device (Predicate Device):
  Since the new models HookSafe™ LUER-LOCK models: 3cc/mL, and 10cc/mL were developed from the cleared device HookSafe™ models: 0.5cc/mL, 1cc/mL, 3cc/mL, and 10cc/mL through the design control procedures of BIOTOP TECHNOLOGY CO., LTD. with only the small change in the needle change mechanism, the new device is substantial equivalence to that of device being modified, HookSafe™ models: 3cc/mL, and 10cc/mL.
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™ models: 3cc/mL, 5cc/mL, and 10cc/mL.

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K043038
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7. Conclusions

The BIOTOP HookSafe™ LUER-LOCK Safety Syringe; models 3cc/mL, and 10cc/mL have the same intended use except for the needle change mechanism and technological characteristics as the cleared device of BIOTOP's model HookSafe™ models: 3cc/mL, 5cc/mL, and 10cc/mL. 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 wavy lines representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 22 2004

Mr. Mark Lien Official Correspondent Biotop Technology Company Limited 12 F-2, No.130, Chung-Hsiao E. Road, Sec.2. Taipei 100, TAIWAN, R.O.C.

Re: K043038

Trade/Device Name: BIOTOP HookSafe LUER-LOCK Safety Syringe; Models 3cc/mL, 5cc/mL, and 10cc/mL Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: December 7, 2004 Received: December 16, 2004

Dear Mr. Lien:

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 - Mr. Lien

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/dsma/dsmamain.html

Sincerely vours.

Susan Ruiano

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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K043038

Indications For Use

510(k) Number (if known):

Device Name: BIOTOP HookSafe™ LUER-LOCK Safety Syringe; models 3cc/mL, and 10cc/mL.

Indications For Use:

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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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).