(48 days)
Not Found
No
The description focuses on the mechanical safety features of a syringe and does not mention any AI or ML components or functionalities.
No
The device is a safety syringe designed for injecting or withdrawing fluids, and its primary function is to serve as a vehicle for medication, not to provide therapy itself.
No
The device is described as a syringe for injecting medication or withdrawing fluid, with a safety mechanism. Its intended use does not involve diagnosing conditions or diseases.
No
The device description clearly describes a physical syringe with mechanical components for safety and anti-reuse, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for injecting medication into the human body or withdrawing fluid from the human body. This is a direct interaction with the patient's body for therapeutic or diagnostic purposes on the patient, not for testing samples outside the body.
- Device Description: The description focuses on the mechanical function of the syringe for injection and withdrawal, and its safety features related to needle sticks and reuse. There is no mention of analyzing samples or providing diagnostic information based on the fluid withdrawn.
- Lack of IVD Characteristics: The description does not include any elements typically associated with IVDs, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of specific analytes
- Providing diagnostic information about a disease or condition
- Use of reagents or assays
The device is a medical device used for administering substances or collecting samples from the body, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for 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models 3cc/mL, and 10cc/mL serves as the vehicle in which medication can be injected into the human body, or fluid withdrawn from the human body, via the hypodermic needle injection.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.
Product codes
MEG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
-
- Name of the Device: BIOTOP HookSafe™ LUER-LOCK Safety Syringe; models 3cc/mL, 5cc/mL, and 10cc/mL.
-
- Information of the 510(k) Cleared Device (Predicate Device): BIOTOP HookSafe™ Safety Syringe, models 3cc/mL, and 10cc/mL (K041970).
-
- 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.
-
- 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.
-
- 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.
- Comparison to the 510(k) Cleared Device (Predicate Device):
-
- 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.
- Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
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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.
2
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.
3
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
4
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:
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.
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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Intection Control. Dental Devices
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