SPECTRA GUIDEWIRE INTRODUCER NEEDLE

K082580 · Spectra Medical Devices, Inc. · DYB · Dec 8, 2008 · Cardiovascular

Device Facts

• Record ID: K082580
• Device Name: SPECTRA GUIDEWIRE INTRODUCER NEEDLE
• Applicant: Spectra Medical Devices, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Dec 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Spectra Guidewire Introducer Needle is intended to be used by medical professionals as introducers/cannula for percutaneous introduction and placement of guidewires in vascular procedures.

Device Story

The Spectra Guidewire Introducer Needle is a manual surgical instrument used by medical professionals in clinical settings. It consists of a stainless steel needle and a colored translucent female Luer lock hub for rapid flashback visualization. The device is available in single-wall style, with or without a Seldinger shield, and with or without an echogenic feature. It is provided in various gauges, lengths, and wall thicknesses. The needle is used to facilitate the percutaneous entry and placement of guidewires into the vasculature. It may be used as a standalone device or incorporated into procedure kits. The device is single-use, sterile, and non-pyrogenic.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing was conducted according to protocols based on FDA guidance and recognized standards to verify equivalence.

Technological Characteristics

Materials: Stainless steel needle, translucent plastic Luer lock hub. Features: Single-wall style, optional Seldinger shield, optional echogenic tip. Sterilization: Ethylene Oxide (ISO 11135:2007). Biocompatibility: ISO 10993. Form factor: Various gauges and lengths. Connectivity: None (manual instrument).

Indications for Use

Indicated for percutaneous introduction and placement of guidewires in vascular procedures for patients undergoing vascular procedures.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Teleflex Medical Introducer Needle (K851140)
• Cook Percutaneous Entry Needle (Reference Medical Device Listing No. 187040)

Submission Summary (Full Text)

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K082580

Do the differences alter the intended therapeutic/diagnostic/etc. effect (i.e. deciding may consider impact on safety and effectiveness)? No, the differences do not alter the intended use of the device.

Does the new device have the same technological characteristics, e.g. design, material, etc.? Yes. The Spectra Guidewire Introducer Needle is substantially equivalent design, materials, and method of use. The basic fundamental scientific technology of the device has not changed.

Could the new characteristics affect safety or effectiveness? No.

Do the new characteristics raise new types of safety and effectiveness questions? No. There are no new types of safety and effectiveness questions.

Do accepted scientific methods exist for assessing effects of the new characteristics? Yes.

Sterilization requirements of ISO 11135:2007, Sterilization of Health Care Products -Requirements for Validation and Routine Control -- Ethylene Oxide Sterilization.

Biocompatibility requirements according to of ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.

These and other standards were used to determine the appropriate methods for evaluating the device's performance.

Are performance data available to assess effects of new characteristics? Yes. Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards and protocols.

Do performance data demonstrate equivalence? Yes. Performance data gathered demonstrated that the Spectra Guidewire Introducer Needle is substantially equivalent to the noted predicate devices.

#### CONCLUSION

The Spectra Guidewire Introducer Needle will meet all established acceptance criteria for performance testing. This testing demonstrated that the Spectra Guidewire Introducer Needle is safe and effective for its intended use, and based on FDA's decision tree is substantially equivalent to the following predicate devices Teleflex Medical Introducer Needle (K851140), and Cook Percutaneous Entry Needle (Pre-amendment device, Reference Medical Device Listing No. 187040).

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# SPECTRA MEDICAL DEVICE, INC.

510(k) Premarket Notification Submission: SPECTRA GUIDEWIRE INTRODUCER NEEDLE

21 CFR 870.4500 Regulation Number: Proprietary Name: Cook Percutaneous Entry Needle (Pre-amendment device, Reference Medical Device Listing No. 187040) Regulation Name: Instruments, Surgical, Cardiovascular Common/Usual Name: Guidewire Introducer Needle Classification Panel: Cardiovascular Regulatory Class: Class II Product Code: DWS Regulation Number: 21 CFR 870.4500

#### DEVICE DESCRIPTION:

The Spectra Guidewire Introducer Needle consists of a stainless steel needle and a colored translucent standard female Luer lock hub locking connector for rapid (flashback) visualization. The Spectra Guidewire Introducer Needle is available in a single-wall style with or without a Seldinger shield. The stainless steel needles are available with and without an echogenic feature. The needles are available in a range of wall thicknesses, gauges and lengths to match the end-user need.

Spectra Guidewire Introducer Needles will be marketed as sterile, non-pyrogenic, and single use devices. Additionally, the device will be marketed as a guidewire introducer needle for use as an accessory in procedure kits. In the case of being used in procedural kits, the product will be shipped bulk non-sterile to the kitting manufacturer. The Spectra Guidewire Introducer Needle will be incorporated into the procedure kit, packaged and sterilized.

## INTENDED USE:

The Spectra Guidewire Introducer Needle is intended to be used by medical professionals as introducers/cannula for percutaneous introduction and placement of guidewires in vascular procedures.

#### INDICATIONS FOR USE:

The Spectra Guidewire Introducer Needle is indicated for percutaneous introduction and placement of guidewires in vascular procedures.

## TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:

New device is compared to Marketed Device? Yes. It is compared to legally marketed predicates.

Does the new device have the same indication statements? Yes.

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#### SPECTRA MEDICAL DEVICE, INC.

510(k) Premarket Notification Submission: SPECTRA GUIDEWIRE INTRODUCER NEEDLE

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (21 CFR 807.92) for Spectra GUIDEWIRE INTRODUCER NEEDLE

#### SUBMITTER:

Spectra Medical Devices, Inc. 260-H Fordham Road Wilmington, Massachusetts, 01887

## ESTABLISHMENT REGISTRATION NUMBER: 1224960

#### CONTACT:

Agustin Turriza QA/RA Manager Telephone: [phone] Fax: [phone] Email: [e-mail]

## DATE PREPARED:

August 21, 2008

# NAME OF MEDICAL DEVICE:

Proprietary Name: Regulation Name: Common/Usual Name:

Spectra Guidewire Introducer Needle Introducer, Catheter Guidewire Introducer Needle

#### DEVICE CLASSIFICATION:

Classification Panel: Regulatory Class: Product Code: Regulation Number: Cardiovascular Class II DYB 21 CFR 870.1340

#### PREDICATE DEVICES:

Proprietary Name: Regulation Name: Common/Usual Name: Classification Panel: Regulatory Class: Product Code:

Teleflex Medical Introducer Needle (K851140) Instruments, Surgical, Cardiovascular Guidewire Introducer Needle Cardiovascular Class II DWS

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and strength. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 0 8 2008

Mr. Agustin Turriza Ouality Assurance/Regulatory Affairs Manager Spectra Medical Devices, Incorporated 260-H Fordham Road Wilmington, Massachusetts 01887

Re: K082580

Trade/Device Name: Spectra Guidewire Introducer Needle Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II Product Code: DYB Dated: August 27, 2008 Received: September 9, 2008

Dear Mr. Turriza:

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. Turriza

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,

Suyte H. Michau us

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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## SPECTRA MEDICAL DEVICE, INC.

510(k) Premarket Notification Submission: SPECTRA GUIDEWIRE INTRODUCER NEEDLE

## Indications For Use

510(k) Number (if known):

Device Name: SPECTRA GUIDEWIRE INTRODUCER NEEDLE

Indications For Use:

The Spectra Guidewire Introducer Needle is indicated for percutaneous introduction and placement of guidewires in vascular procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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)

A

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

510(k) Number: 482580