The BIOTOP DJT-A Safety Syringe (3cc/mL) serves as the vehicle in which medication can be injected into the human body, or fluid withdrawn from the human body, via the hypodermic needle injection.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 BIOTOP DJT-A Safety Syringe is a single-use hypodermic syringe that is very similar to a traditional syringe, except it possesses an integral needle retracting mechanism. Upon employing traditional syringe injection techniques, the needle can be manually retracted back inside the syringe barrel.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text for the BIOTOP DJT-A Safety Syringe:

Note: This document is a 510(k) Summary, which is a premarket notification for medical devices. The primary goal of a 510(k) is to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove the device meets specific performance acceptance criteria through extensive clinical trials as might be required for a PMA (Premarket Approval). Therefore, the "acceptance criteria" here are framed within the context of demonstrating equivalence.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied for Substantial Equivalence to DuoProSS™)	Reported Device Performance (BIOTOP DJT-A Safety Syringe)
Similar parts, design, material, operating procedure, and intended use to DuoProSS™.	Similar to DuoProSS™ in parts, design, material (PP plastic, lubricant, needle), operating procedure, and intended use.
Similar performance data under all conditions and stress as DuoProSS™.	"Performed bench testing revealed similar performance data, under all conditions and stress."
As safe and effective in its performance as DuoProSS™ in simulated field tests.	"Simulated field test suggests that the DJT-A is as safe and effective in its performance as the DuoProSS™."
Limits accidental needlestick injuries.	"The safety mechanism may limit accidental needlestick injuries..."
Helps to prohibit syringe reuse.	"...as well as help to prohibit syringe reuse."
Sterile and aseptic.	Sterile and aseptic, employing ethylene oxide (EO) sterilization.
Biocompatible.	Biocompatibility testing performed.
Meets requirements outlined in "Supplementary Guidance on Premarket Notification for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA."	All required testing (Bench, biocompatibility, sterility, substantial equivalence, simulated clinical testing) employed according to the FDA guidance document.

Study Details

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not explicitly stated. The document mentions "Performed bench testing" and "simulated field test" without providing specific sample sizes for these tests.
- Data Provenance: The submitting company is BIOTOP Technology Co., Ltd. from Taiwan. The testing was conducted as part of their 510(k) submission. It's implied these were prospective tests conducted to support the submission.
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. The ground truth for performance was established through bench testing and simulated field testing, where the device's technical specifications and functional performance were compared to a predicate device. There is no mention of human expert evaluation in the establishment of ground truth for these tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This type of adjudication is typically used for clinical studies involving human interpretation or subjective evaluations. The described performance testing (bench and simulated field tests) are objective measurements without the need for human adjudication in this context.
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 mechanical safety syringe, not an AI software or diagnostic imaging device. Therefore, MRMC studies are not relevant.
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 performance described is "standalone" in the sense that the device itself was tested, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" was the performance of the predicate device (M.K. Meditech's DuoPro Safety Syringe) and the established engineering and safety standards (as per FDA guidance for sharps injury prevention features). The BIOTOP DJT-A Safety Syringe's performance was compared against these.
- Specifically for the safety features, the ground truth relates to the physical mechanism effectively limiting accidental needle sticks and prohibiting reuse, which would be evaluated against engineering specifications and industry standards for safety syringes.
The sample size for the training set:
- Not applicable. This is a physical device, not a machine learning model. There is no "training set" in the context of device development as described here.
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned for this type of device submission.

Summary

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MAY 11 2004

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K032717

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510(K) Summary of Safety and Effectiveness II.

Information

(Per 21 CFR 807.92)

BIOTOP Technology Co., Ltd. 1. Submitter: 12F, No. 130, Chung-Hsiao E. Rd. Sec. 2 Taipei 100 Taiwan

Contact Person: Dr. Ke-Min Jen Official Correspondent 886-3-5208829 (Tel) 886-3-5209783 (Fax)

Date Prepared: 2003/6/13 2.
1. Device Name:

BIOTOP DJT-A Safety Syringe -Proprietary Name: Sharps Injury Prevention Piston Syringe -Common Name: -Classification Name: Antistick Syringe (MEG)

Prcdicate Device: 4.

Claim of Substantial Equivalence (SE) is made to M.K. Meditech Company's DuoPro Safety Syringe (DuoProSSTM) (K020623, K022806).

5. Device Description:

Intended Use: 6.

The BIOTOP DJT-A Safety Syringe 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 needlestick injuries as well as help to prohibit syringe reuse.

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7. Substantial Equivalence (SE) and Safety and Effectiveness Information:

BIOTOP Technology Co., Ltd. makes a Substantial Equivalence claim of the DJT-A safety syringe to M.K. Meditech's DuoProSS™. The two safety syringes are similar with regards to parts, design, material, operating procedure, and intended use, The DJT-A and the DuoProSS™ both consist of a syringe barrel, syringe plunger, single lumen hypodermic needle and needle hub, and a retracting mechanism on the syringe plunger head and the needle hub. The DJT-A needle employs a luer-lock mechanism while the DuoProSS™ can be both luer-slip or luer-lock. The design of the two syringes is similar in most of its parts, appearing like a traditional syringe. The DJT-A and DuoProSS™ uses identical PP plastic, lubricant, and needle. Both safety syringes are sterile and aseptic by employing ethylene oxide (EO) as the sterilization technique. The difference between the two safety syringes is the needle retracting mechanism. Both use a special tip on the head of the syringe plunger to be tightly connected to the needle hub as to allow the whole hub and necdle to be manually retracted back inside the plunger. The difference between the two is the shape of the connecting tip on the syringe plunger. The DJT-A uses a hook to connect to the needle hub while the DuoProSS™ uses a knob-shaped tip to connect to the However, the operating instructions for both safety syringes are needle hub. identical with regards to how the needle is retracted back into the syringe barrel. Performed bench testing revealed similar performance data, under all conditions and stress. In addition, simulated field test suggests that the DJT-A is as safe and effective in its performance as the DuoProSS™. Therefore, no new safety and effectiveness concerns need to be raised. In addition, both syringes share identical purposes in its intended use. The DJT-A and the DuoProSS™ single-use safety syringes both intend to limit disease transmission through accidental necdlestick injurics and through syringe reuse.

8. Performance Testing:

Bench, biocompatibility, sterility, substantial equivalence, and simulated clinical testing are employed upon submission of this 510(K) premarket notification according to the Supplementary Guidance on Premarket Notification for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA document provided by CDRH/ FDA.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 11 2004

ROC Chinese-European Industrial Research Society C/O Dr. Ke-Min Jen Official Correspondent Biotop Technology Company Limited 58 Fu-Chiun Street Hsin Chu City, CHINA (TAIWAN) 300

Rc: K032747

Trade/Device Name: BIOTOP DJT-A Safety Syringe (3cc/mL) Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: February 12, 2004 Received: February 20, 2004

Dear Dr. Jen:

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 - Dr. Jen

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. or the rever 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 and if the (21 ce e forth in the quality systems (QS) regulation (21 CFR Part 820); and if roquicable, 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 (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may 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

Sincerely yours,

Smakunna

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 Statement IV.

Applicant: BIOTOP TECHNOLOGY CO., LTD.

510(k) Number:

Device Name: BIOTOP DJT-A Safety Syringe (3cc/mL)

Indications for Use:

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)

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Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number:_ K

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).