BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML

K041970 · Biotop Technology Co., Ltd. · MEG · Aug 3, 2004 · General Hospital

Device Facts

• Record ID: K041970
• Device Name: BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML
• Applicant: Biotop Technology Co., Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Aug 3, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BIOTOP HookSafe™ Safety Syringe; models 0.5cc/mL, 1cc/mL, 3cc/mL, 5cc/mL, and 10cc/mL serves as the vehicle in which medication can be injected into the human body, or fluid withdrawn from the human body, via the hypodermic needle injection.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 help to prevent needlestick injuries as well as help to prohibit syringe reuse.

Device Story

Manual piston syringe; used for medication injection or fluid withdrawal. Features integrated safety mechanism; upon full plunger depression, internal mechanism engages and locks needle; needle retracts into syringe barrel; prevents reuse and accidental needlestick injuries. Operated by clinicians or healthcare providers in clinical settings. Output is physical delivery of medication or fluid collection; safety feature provides passive protection post-injection.

Clinical Evidence

Bench testing only.

Technological Characteristics

Piston syringe with integrated anti-needlestick and anti-reuse locking mechanism. Manual operation. Materials and dimensions consistent with predicate device.

Indications for Use

Indicated for injection of medication into or withdrawal of fluid from the human body via hypodermic needle. Intended to prevent needlestick injuries and prohibit syringe reuse.

Regulatory Classification

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.

Predicate Devices

• BIOTOP DJT-A (3cc/mL) (K032747)

Submission Summary (Full Text)

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## 510(K) SUMMARY

K0419-70

AUG - 3 2004

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

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________ Submitter's Identifications: Company: BIOTOP TECHNOLOGY CO., LTD. Company: BIOTOP TECHNOLOGT OO:, ETD:
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: Name of the Device:
BIOTOP HookSafe™ Safety Syringe; models 0.5cc/mL, 1cc/mL, 3cc/mL, and 10cc/mL.
- 2. Information of the 510(k) Cleared Device (Predicate Device): BIOTOP DJT-A (3cc/mL) (K032747).
- 3. Device Description:
- Device Deschiption:
The HookSafe" series is the Safety Syringe with the following functional advantage:
- The HookSale Senest is the Galoty of hirs and components can be completely self-destroyed and safely discarded.
- <B> Fully meets anti-needlestick requirements and incorporates anti-neuse functionality as well. As Pully theets anti-fiecalestion requirements and the syringe plunger should be fully with any normal synnge, and the this this strum. It is at this stage where the anti-reuse needle depressed to ensure complete injoction in the seringe engages the syringe needle
function of our syringe begins; a mechanism within our syringe engages and function of our synnge begins, a moonaniems to pull the syringe plunger back again and and forms a lock. At this point, one almily noces to the syringe. Because the needle, the needle will be completely rotracted into the sareed against the inner shoulder of the when retracted, is in a subly tills pose becomes completely harmless and fully meets its anti-reuse functionality.
- 4. Intended Use:

The BIOTOP HookSafe™ Safety Syringe; models 0.5cc/mL, 1cc/mL, 3cc/mL, 3cc/mL, and The BIOTOF TrookSale - Galexy Cynnigo, modication can be injected into the human body, or fluid Tocomic serves as the vehicle in which modernic needle injection. The safety mechanism may withdrawn from the naman injuries as well as help to prohibit syringe reuse.

- 5. Comparison to the 510(k) Cleared Device (Predicate Device):
Companson to the STUK) Gleared Device (1 redicate Bother).
Since the new models HookSafe™ models: 0.5cc/mL, 1cc/mL, 3cc/mL, 5cc/mL, and 10cc/mL were Since the new models noolOuic - model the design control procedures of developed from the cleared device Boy A (contine) name in dimension and device housing, DIOTOF TECHINGEOOT OO., Enternance to that of device being modified, DJT-A (3cc/mL).

6. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:

ത്രിമ്പിച്ച് എന്നിവ DJT-A (3cc/mL).

- 7. Conclusions
The BIOTOP HookSafe™ Safety Syringe; models 0.5cc/mL, 1cc/mL, 3cc/mL, 3cc/mL, and The BIOTOF ThookOate - odalery offings a characteristics as the cleared device of Tocomic have the same intended aso and to mistication and validation tests contained in this BIOTOF's model Do F-A (SCAME). Moroover, N.H.Readonitted 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/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 3 2004

Mr. Mark Lien Official Correspondent BIOTOP Technology Company Limited 12 F-2. No.130 Chung-Hsiao East Road, Sec.2 Taipei 100, Taiwan Republic of China

Re: K041970

Trade/Device Name: BIOTOP HookSafe™ Syringe; Models 0.5cc/mL, 1cc/mL, 3cc/mL, 5cc/mL, and 10cc/mL Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: July 20, 2004 Received: July 22, 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 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu-Lin, Ph.D.

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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KO41970

## Indications For Use

510(k) Number (if known):

Device Name: BIOTOP HookSafe™ Safety Syringe; models 0.5cc/mL, 1cc/mL, 5cc/mL, 5cc/mL, and 10cc/mL.

Indications For Use:

The BIOTOP HookSafe™ Safety Syringe; models 0.5cc/mL, 1cc/mL, 3cc/mL, 5cc/mL, and The BIOTOF Tiookoule - Gallery Cymhy of the medication can be injected into the human body, or fluid withdrawn from the human body, via the hypodermic needle injection. The safety muld withdrawn from the haman 2007, netick injuries as well as help to prohibit syringe reuse.

Prescription Use (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)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chr. Hansen

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:________________________________________________________________________________________________________________________________________________________________

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