(147 days)
Not Found
No
The description focuses on mechanical safety features and does not mention any computational or data-driven components.
No
The device is a syringe used for injecting medication, not for providing therapy itself. Its primary function is a delivery mechanism, with safety features to prevent reuse and accidental needle sticks.
No
The device is described as an insulin syringe for injecting medication into the human body, not for diagnosing medical conditions.
No
The device description clearly outlines a physical syringe with a safety mechanism and anti-reuse functionality, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to inject medication (insulin) into the human body. This is a direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description focuses on the mechanism for safe injection and preventing reuse, not on analyzing samples from the body.
- Anatomical Site: The anatomical site is the human body, indicating a direct in-vivo application.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is a delivery system for medication, which falls under the category of a therapeutic or drug delivery device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MEG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human body
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
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- 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.
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.
- Intended Use:
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.
1
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).
-
- 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).
- Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
-
- 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.
- Conclusions
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 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:
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.
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)
(
In-Off)
ora of Anesthesiology. General Hosp
un Control, Dental Devices
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