(74 days)
The InsoSAFE™ Bak'SNAP™ Retractable Insulin Safety Syringe is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe intended for subcutaneous injection of insulin into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
The InsoSAFE™ Bak'SNAP™ Retractable Insulin Safety Syringe is a sterile, singleuse, disposable and non-reusable, manual, retractable safety syringe intended for injection of insulin into the body, while reducing the risk of sharps injuries and the potential for syringe reuse. It is a sterile, single-use, with a pre-attached single lumen hypodermic needle. Syringe volumes include 1 mL, 0.5 mL, and 0.3 mL. Needles range in size from 25G to 29G, with lengths of 3/8 inch to 1/2 inches. The InsoSAFE™ is provided individually wrapped, in shelf boxes of 100 units.
The provided text describes a 510(k) submission for the InsoSAFE™ Bak'SNAP™ Retractable Insulin Safety Syringe. This document details the device's characteristics, intended use, and claims of substantial equivalence to predicate devices. It explicitly mentions "Verification and validation testing presented in this premarket notification includes testing to demonstrate conformance to standards and testing according to FDA guidance, 'Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions for Medical Devices with Sharps Injury Protection Features, December 2002'".
However, the document does not provide any specific acceptance criteria or detailed study results that prove the device meets these criteria. It states that testing was done to conform to standards and FDA guidance, but the actual results, sample sizes, ground truth establishment, or expert involvement are not included in this summary.
Therefore, I cannot populate the requested table or provide information about the study's specifics as those details are not present in the provided text.
Specifically, the following information is missing from the provided text:
- A table of acceptance criteria and the reported device performance: Not present.
- Sample sizes used for the test set and the data provenance: Not present. The text only mentions "testing" without any numbers or data source details.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth is mentioned for a diagnostic or AI device. This is a medical device (syringe), not a diagnostic or AI product.
- Adjudication method for the test set: Not applicable as no ground truth establishment is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI or diagnostic imaging device.
- If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no ground truth for performance is detailed.
- The sample size for the training set: Not applicable, as this is a physical medical device, not a machine learning model.
- How the ground truth for the training set was established: Not applicable, as this is a physical medical device.
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APR 5 2005
K050/31/
page 1 of 2
510(k) Summary InsoSAFE™ Bak'SNAPTM Retractable Insulin Safety Syringe (per 21CFR807.92)
l. SPONSOR
M.K. Meditech Co., Ltd. 18-38, No. 50, Sec. 1 Jhong Siao W. RD. Taipei, 100 Taiwan, ROC
Contact Person: Kenny Chiang, QA Manager Telephone: 02-23710558
Date Prepared: January 13, 2005
2. DEVICE NAME
| Proprietary Name: | InsoSAFET™ Bak'SNAP™ Retractable Insulin SafetySyringe | ||||
|---|---|---|---|---|---|
| Common/Usual Name: | Insulin syringe | ||||
| Classification Name: | Piston syringeHypodermic single lumen needle |
3. PREDICATE DEVICES
- 1 mL Bak'SNAP™ DuoProSS™ (K031594) .
- Inviro Snap Safety Syringe (K040036) .
- BD Safety-Glide (K992734) .
4. DEVICE DESCRIPTION
The InsoSAFE™ Bak'SNAP™ Retractable Insulin Safety Syringe is a sterile, singleuse, disposable and non-reusable, manual, retractable safety syringe intended for injection of insulin into the body, while reducing the risk of sharps injuries and the potential for syringe reuse. It is a sterile, single-use, with a pre-attached single lumen hypodermic needle. Syringe volumes include 1 mL, 0.5 mL, and 0.3 mL. Needles
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range in size from 25G to 29G, with lengths of 3/8 inch to 1/2 inches. The InsoSAFE™ is provided individually wrapped, in shelf boxes of 100 units.
INTENDED USE న.
The InsoSAFE™ Bak'SNAP™ Retractable Insulin Safety Syringe is a sterile, singleuse, disposable and non-reusable, manual, retractable safety syringe intended for subcutaneous injection of insulin into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
M.K. Meditech Co., Ltd., makes a claim of substantial equivalence of the InsoSAFE™ Bak'SNAP™ to the cited predicates based on similarities in intended use, design, and technological and operational characteristics. The syringes are indicated for injecting insulin into the body, while helping to reduce the risk of sharps The InsoSAFE™ Bak'SNAPTM and cited predicate syringes have injuries. permanently attached, single-lumen hypodermic needles. All syringes are available in 1 mL volumes and the InsoSAFE and BD syringes are also available in 0.5 mL and 0.3 mL versions.
All syringes are provided sterile, single-use, and disposable. The InsoSAFE and the Inviro Snap syringes have two-part plungers. The distal part holds the hypodermic needle and the proximal part has a projection spike that mates with the distal part, thereby locking the needle to the plunger. All syringes require the user to manually activate the safety mechanism. For the InsoSAFE and the Inviro Snap, this is done by retracting the needle-plunger into the syringe barrel, breaking off the plunger rod, and discarding the pieces. For the BD Safety-Glide, the user advances a protective sheath over the used needle. M.K. Meditech Co., Ltd., believes that the differences between the 1 mL DuoPro™ Safety Syringe and cited predicate devices are minor and they raise no new issues of safety or effectiveness.
7. TESTING
Verification and validation testing presented in this premarket notification includes testing to demonstrate conformance to standards and testing according to FDA guidance, "Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions for Medical Devices with Sharps Injury Protection Features, December 2002"
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged 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
APR 5 2005
2005
M.K. Meditech Company Limited C/O Ms. Rosina Robinson, RN, MEd, RAC Senior Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K050131
Trade/Device Name: M.K. Meditech Co., Ltd., InsoSAFETM Bak'SNAPTM Retractable Insulin Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: January 20, 2005 Received: January 21, 2005
Dear Ms. Robinson:
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. Robinson
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 (OS) 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 (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,
Chi-Li, 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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510(k) Number (if known):
Device Name: M.K. Meditech Co., Ltd., InsoSAFE™ Bak'SNAP™ Retractable Insulin Safety Syringe
Indications For Use:
The InsoSAFE™ Bak'SNAP™ Retractable Insulin Safety Syringe is a sterile, single-use, disposable and non-reusable, manual, retractable safety syringe intended for subcutaneous injection of insulin into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
Prescription Use (21 CFR 801 Subpart D) OR
Over-The-Counter Use X (21 CFR 807 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Ate V. in
100 Simil ion of Anasthesiology, General Hospital n Control Dental Devices
Number.
M. K. Meditech Co., Ltd. March 29, 2005 InsoSAFE™ Bak'SNAP™ Retractable Insulin Safety Syringe · Response to FDA Request for Additional Information for K050131
§ 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).