INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE

K050131 · M.K. Meditech Co. , Ltd. · MEG · Apr 5, 2005 · General Hospital

Device Facts

• Record ID: K050131
• Device Name: INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE
• Applicant: M.K. Meditech Co. , Ltd.
• Product Code: MEG · General Hospital
• Decision Date: Apr 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

InsoSAFE™ Bak'SNAP™ is a manual, retractable safety syringe for subcutaneous insulin delivery. Device features pre-attached single-lumen hypodermic needle (25G-29G, 3/8"-1/2"). Operation involves manual injection followed by user-activated safety mechanism: retracting needle-plunger into barrel, breaking off plunger rod, and discarding components to prevent reuse and sharps injury. Available in 1 mL, 0.5 mL, and 0.3 mL volumes. Used in clinical or home settings by patients or healthcare providers. Benefits include reduced risk of accidental needlestick injuries and prevention of syringe reuse.

Clinical Evidence

Bench testing only. Verification and validation testing performed to demonstrate conformance to standards and FDA guidance, "Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions for Medical Devices with Sharps Injury Protection Features, December 2002."

Technological Characteristics

Manual, retractable piston syringe. Two-part plunger design with projection spike for needle locking. Available in 1 mL, 0.5 mL, 0.3 mL volumes. Needle gauges 25G-29G; lengths 3/8"-1/2". Sterile, single-use, disposable. No electronic components or software.

Indications for Use

Indicated for subcutaneous insulin injection in patients requiring insulin therapy. Suitable for OTC use.

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

• 1 mL Bak'SNAP™ DuoProSS™ (K031594)
• Inviro Snap Safety Syringe (K040036)
• BD Safety-Glide (K992734)

Submission Summary (Full Text)

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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: [phone]

Date Prepared: January 13, 2005

#### 2. DEVICE NAME

| Proprietary Name: | InsoSAFET™ Bak'SNAP™ Retractable Insulin Safety<br>Syringe | | | | |
|----------------------|------------------------------------------------------------|--|--|--|--|
| Common/Usual Name: | Insulin syringe | | | | |
| Classification Name: | Piston syringe<br>Hypodermic 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 [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/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)

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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