The Manual Safety Syringe is a single-use safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.

Device Description

The Manual Safety Syringe is a single-use safety hypodermic syringe, which is very similar to a traditional syringe, with the exception that it possesses an integral needle retracting mechanism. The device comes in two variations:

3. Manual Safety Syringe (2-parts) 5ml
1. Manual Safety Syringe (3-parts) 5ml
  The Manual Safety Syringe (2-parts) consists of a conventional syringe barrel equipped with a mechanism that shall prevent re-use of an already used syringe. When the plunger is pressed in its bottom position the injection is completed. When retracting the plunger the snare will drag the needle into the barrel, and thus prevent reuse of the syringe. The cone prevents the needle from going back into the barrel during the injection. The nozzle holds the needle, snare and cone and is attached to the barrel prior to injection. The needle cap protects the needle when handled. Also, when pulled back, the plunger is unable to be detached from the barrel. As an additional safety feature the operator is encouraged to break off the plunger when the plunger has been pulled back.
  The Manual Safety Syringe (3-parts) is identical to the 2-parts version with respect to the operation of the device. The design differs only with respect to the plunger and the lubrication. The 3-parts version is equipped with an extra sealing and the inside of the barrel is lubricated with silicon. The 2-parts version is not lubricated.
  The Manual Safety Syringe is only available in one size (5ml).

AI/ML Overview

This document is a 510(k) summary for the Manual Safety Syringe, indicating it is not a study reporting acceptance criteria and device performance. The summary claims substantial equivalence to a predicate device and states that a "clinical evaluation has volunary standards, and the results show that the Manual Safety Syringe 5ml is clinically acceptable." However, it does not provide specific details about the clinical evaluation or clearly define acceptance criteria. It mentions "biocompatibility testing, compliance with production and comparison to the predicate device" as contributing to the conclusion of substantial equivalence.

Therefore, I cannot provide the requested information from the given text as it is not present. The document focuses on regulatory approval based on demonstrating substantial equivalence to a legally marketed device rather than providing a detailed report of acceptance criteria and a study proving those criteria were met for this specific device.

Summary

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OCT 16 2006

H 510(k) Summary – Traditional Submission

510(k) Owner

Establishment:	MedSafe ASA
Address:	Forskningsveien 2A, N-0373 Oslo, Norway
Phone:	+47 23 22 36 14
Fax:	+47 22 14 02 55

Contact Person

Name:	Nils Gunnarsson
Establishment:	MedSafe ASA
Address:	Forskningsveien 2A, N-0373 Oslo, Norway
Phone:	+47 23 22 36 14
Fax:	+47 22 14 02 55

Date of Preparation

March 9, 2006

ldentification of the Device

1. Proprietary Name:	Manual Safety Syringe (2-parts),Manual Safety Syringe (3-parts)
2. Common Name:	Sharps Injury Prevention Piston Syringe
3. Classification Name:	Antistick Syringe
4. Class II, Procodes:	FMF - Piston SyringeMEG – Antistick SyringeFMI – Hypodermic Single Lumen Needle

Equivalent Legally Marketed Device

Claim of Substantial Equivalence is made to BIOTOP DJT-A Safety Syringe (K032747).

Intended Use

The Manual Safety Syringe is a single-use safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.

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Description of the Device

1. Manual Safety Syringe (2-parts) 5ml
1. Manual Safety Syringe (3-parts) 5ml

The Manual Safety Syringe (2-parts) consists of a conventional syringe barrel equipped with a mechanism that shall prevent re-use of an already used syringe. When the plunger is pressed in its bottom position the injection is completed. When retracting the plunger the snare will drag the needle into the barrel, and thus prevent reuse of the syringe. The cone prevents the needle from going back into the barrel during the injection. The nozzle holds the needle, snare and cone and is attached to the barrel prior to injection. The needle cap protects the needle when handled. Also, when pulled back, the plunger is unable to be detached from the barrel. As an additional safety feature the operator is encouraged to break off the plunger when the plunger has been pulled back.

The Manual Safety Syringe (3-parts) is identical to the 2-parts version with respect to the operation of the device. The design differs only with respect to the plunger and the lubrication. The 3-parts version is equipped with an extra sealing and the inside of the barrel is lubricated with silicon. The 2-parts version is not lubricated.

The Manual Safety Syringe is only available in one size (5ml).

	The Manual Safety Syringe	BIOTOP DJT-A Safety Syringe
Syringe type	Antistick syringe	Antistick syringe
Intended use	The Manual Safety Syringe is a single-use safety hypodermic syringe for intramuscular and subcutaneous injection of medication to patients. This device aids in prevention of needlestick injuries.	Similar
Principle of operation	Activation of safety feature consists of three steps:1) Press the plunger to the bottom position to complete injection.2) Retract the plunger to full stop to drag the needle into the barrel.3) Brake plunger off.	Identical
Volume (ml/cc)	5ml	1ml/3ml/5ml
Nozzle type	Luer	Luer Lock Tip
Barrel		Identical

Safety and Effectiveness, Comparison to Predicate Device

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marking
Reuse	Non-reusable	Identical
Materials	1. Barrel:Polypropylene	Polypropylene
	2. Plunger:Polyethylene	Polypropylene
	3. SnarePolypropylene	N/A
	4. Needle:Stainless steel	Stainless steel
	5. Cone:Polycarbonate	N/A
	6. Nozzle:Polycarbonate	Polypropylene
	7. SealingThermoplastic Elastomer Compound	Unknown
	8. LubricationSilicon lubrication	Unknown
	9. Needle capPolypropylene	Unknown
	10. Primary container:Peel-packs made of plastic	Unknown
	11. Secondary container:Cardboard box	Unknown
	12. Transport container:Corrugated cardboard	Unknown
Sterility	Sterilized by ethylene oxide gas	Sterilized by ethylene oxide gas
	SAL < $10^{-6}$	SAL = $10^{-6}$

Table 10 Table of Comparison

Conclusion

In all material respects, the Manual Safety Syringe is substantially equivalent to the m an material respects) also hambabased on biocompatibility testing, compliance with production and comparison to the predicate device. A clinical evaluation has volunary standards, and the results show that the Manual Safety Syringe 5ml is clinically acceptable.

End of 510(k) summary

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ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

0C1 16 2006

Mr. Jan-Erik Mikkelborg Managing Director MedSafe ASA Forskningsveien 2A N-0373 Oslo, Norway

Re: K060772

Trade/Device Name: Manual Safety Syringe MS 1178-2 (5ml, 22G, 1 1/4") Manual Safety Syringe MS 1178-3 (5ml, 22G, 11/4") Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: September 13, 2006 Received: September 18, 2006

Dear Mr. Mikkelborg:

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 – Mr. Mikkelborg

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 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,

Chris Liu, 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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C Indications for Use

510(k) Number (if known): ____K060772

Manual Safety Syringe_MS 1178-2 (5 ml, 22G, 1 1/4")_ Device Name: Manual Safety Syringe_MS 1178-3 (5 ml, 22G, 1 1/4")_

Indications for Use:

The Manual Safety Syringe is a single-use safety hypodermic syringe for intramuscular and subcutaneous injection of medication. This device aids in prevention of needle stick injuries.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE.DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Solllll for Anthony D. Watson
(0)1/6/2004

of Anesthesiology, General Hospital on Control, Dental Devices

umber: K66722

Side: 12 of 12

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).