K-PACK II NEEDLE - 29G THIN WALL

K082820 · Terumo Europe N.V. · FMI · Oct 23, 2008 · General Hospital

Device Facts

• Record ID: K082820
• Device Name: K-PACK II NEEDLE - 29G THIN WALL
• Applicant: Terumo Europe N.V.
• Product Code: FMI · General Hospital
• Decision Date: Oct 23, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 29G Thin Wall K-Pack II Needle being a Hypodermic Single Lumen Needle is a sterile medical device for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Device Story

Sterile, single-use hypodermic single lumen needle; consists of stainless steel tube sharpened at one end and attached to polypropylene female luer hub. Designed for connection to male luer nozzle of piston syringe. Used by healthcare professionals to inject or withdraw fluids below skin surface. Device extension of existing K-Pack II line featuring thinner cannula wall and shorter packaging case. Benefits include clinical utility for fluid administration/aspiration.

Clinical Evidence

Bench testing only. No clinical data provided. Sterility validated per EN 550/ISO 11135; EtO residuals compliant with EN ISO 10993-7; biocompatibility tested per ISO 10993-1.

Technological Characteristics

Stainless steel cannula; polypropylene hub. Externally communicating, blood-contacting (limited exposure ≤ 24 hrs). Sterilized via ethylene oxide (EtO). Dimensions: 29G thin wall. Standalone device.

Indications for Use

Indicated for patients requiring injection of fluids into or withdrawal of fluids from body areas below the skin surface. Single-use device.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• K-Pack II Needles (K984576)
• 29 Gauge & 30 Gauge K- Pack II Needles (K062608)

Submission Summary (Full Text)

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Körzno

OCT 2 3 2008

## 510(k) SUMMARY

Prepared for: TERUMO EUROPE N.V. Researchpark Zone 2, Interleuvenlaan 40, 3001 Leuven, BELGIUM

Prepared by: Mrs. M.J. Aerts - Manager Regulatory Affairs Tel. [phone] Fax [phone]

September 2008 Date prepared:

Note: Class III Summary & Certification is not applicable for the submission of a Class II device

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## II. 510(k) SUMMARY

- II.1. Device Name
- II.2. Reason for Submission
- II.3. Intended Use
- II.4. Description
- II '2 Substantial Equivalence
- II.6. Additional Safety Information

- Ш.7. Conclusion

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### 510(k) SUMMARY as required by 807.92 Summary of Safety & Effectiveness Information

#### II.l. Device Name

Proprietary Name K-Pack II Needle - 29G Thin Wall Classification Name Hypodermic Single Lumen Needle 21CFR. Section 880.5570 Classification: Class II

#### 11.2. Reason for Submission

This 510k is being submitted to extend the cleared K-Pack II Needle (K984576) product line. The cannula wall of this 29G needle is thinner than what is currently cleared under the K-Pack II Needle 510k (K062608) for the 29 Gauge needle. In addition, the 29G Thin Wall K-Pack II Needle is packaged in a short case instead of a long one as cleared in K062608. This Special 510k is therefore being submitted due to potential issues of safety and effectiveness specific for a thinner needle and the shorter case. This 510k will provide supporting information that the 29G Thin Wall K-Pack II Needle is safe and effective and an acceptable extension of the current K-Pack II Needle product line.

#### II.3. Intended Use

The 29G Thin Wall K-Pack II Needle being a Hypodermic Single Lumen Needle is a sterile medical device for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Note: This is the same intended use as the predicate device, K-Pack II Needle – K984576 and 29 Gauge & 30 Gauge K- Pack II Needles (K062608)

### II.4. Description

The 29G Thin Wall K-Pack II Needle is a sterile hypodermic single lumen needle, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a malc connector (nozzle) of a piston syringe.

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### 11.5. Substantial Equivalence

The 29G Thin Wall K-Pack II Needle is substantially equivalent in intended use, design, technology/principal of operation, materials, and performance to the following cleared devices:

- 1. K-Pack II Needles (K984576)
- 2. 29 Gauge & 30 Gauge K- Pack II Needles (K062608)

Differences between the devices do not raise any significant issues of safety and effectiveness.

### II.6. Additional Safety Information

The sterility of 29G Thin Wall K-Pack II Needle is assured by using a validated sterilization method qualified in accordance with EN 550: "Sterilization of Medical Devices: Validation and routine control of ethylene oxide" and ISO 11135: "Medical Devices: Validation and routine control of ethylene oxide sterilization" to a sterility assurance level (SAL) of 106 as required by EN 556-1: "Sterilization of Medical Devices - Requirements for medical devices to be designated "STERILE" - Part - 1: Requirements for terminally sterilized medical devices" and EN 556-1/AC (2006).

Ethylene oxide residual levels resulting from EtO sterilization are in compliance with EN ISO 10993-7: "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals"

The 29G Thin Wall K-Pack II Needle, like the standard K-Pack II Needle (K984576), is an Externally Communicating device, Contacting Circulating Blood, Limited Exposure (≤ 24 hrs). The device's blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part-1: Evaluation and testing".

The expiration dating for the 29G Thin Wall K-Pack II Needle has been established at 5 years which is the same as the cleared K-Pack II Needles.

### II.7. Conclusion

In summary, the 29G Thin Wall K-Pack II Needle is substantially equivalent in intended use, design, technology/principal of operation, materials, and performance to the following cleared devices:

- 1. K-Pack II Needles (K984576)
- 2. 29 Gauge & 30 Gauge K- Pack II Needles (K062608)

Differences between the devices do not raise any new issues of safety or effectiveness.

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Image /page/4/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mrs. MJ Aerts Regulatory Affairs Manager TERUMO Europe N.V. Interleuvenlaan 40 Researchpark Zone 2 Leuven, Belgium 3001

# OCT 2 3 2008

Re: K082820

Trade/Device Name: K-Pack II Needle - 29G Thin Wall (hypodermic needle) Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: September 18, 2008 Received: September 25, 2008

Dear Mrs. Aerts:

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 - Mrs. Aerts

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Chih S. Lin, Ph.D.

Chiu S. Lin. Ph. D Division 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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# Indication for Use

510(k) Number (if known):

Device Name: K-Pack II Needle - 29G Thin Wall (hypodermic needle)

Indication For Use:

The 29G Thin Wall K-Pack II Needle being a Hypodermic Single Lumen Needle is a sterile medical device for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Charles Biber for HD)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K082820