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.

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

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 Guidewwire Introducer Needle will be incorporated into the procedure kit, packaged and sterilized.

AI/ML Overview

The provided text describes the submission of a 510(k) premarket notification for the Spectra Guidewire Introducer Needle, arguing its substantial equivalence to predicate devices rather than claiming novel effectiveness. Therefore, the document does not contain a study that proves the device meets specific performance acceptance criteria in the way a clinical trial or algorithm validation study would. Instead, it focuses on demonstrating that the device is safe and effective for its intended use by meeting established standards and exhibiting similar technological characteristics to legally marketed predicate devices.

Here's a breakdown based on your request, highlighting what information is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The submission mentions that "The Spectra Guidewire Introducer Needle will meet all established acceptance criteria for performance testing" and that "Performance data gathered demonstrated that the Spectra Guidewire Introducer Needle is substantially equivalent to the noted predicate devices." However, the specific quantitative acceptance criteria (e.g., tensile strength, flow rates, sharp-ness specifications) and the precise reported performance values are not detailed in the provided text.

The acceptance criteria are generally framed around adherence to recognized standards for medical devices and comparison to predicate devices, rather than novel performance benchmarks.

Acceptance Criteria Category	Reported Device Performance
Sterilization Requirements	Meets ISO 11135:2007 (Ethylene Oxide Sterilization).
Biocompatibility Requirements	Meets ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. (Implicitly, the device passed these tests and is considered biocompatible).
Technological Characteristics	Substantially equivalent design, materials, and method of use to predicate devices (Teleflex Medical Introducer Needle (K851140) and Cook Percutaneous Entry Needle (Pre-amendment device, Reference Medical Device Listing No. 187040)). This implies performance in aspects like needle stiffness, tip geometry, hub connection, flashback visualization, etc., are comparable to the predicates.
Safety and Effectiveness	Demonstrated safe and effective for its intended use, based on FDA's decision tree for substantial equivalence. This is a conclusion based on the combined assessment of materials, design, manufacturing, and comparison to predicates.
Intended Use & Indications	Shares the same intended use and indications for use as predicate devices: "intended to be used by medical professionals as introducers/cannula for percutaneous introduction and placement of guidewires in vascular procedures."

2. Sample Size Used for the Test Set and Data Provenance

The document states that "Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards and protocols." However, the sample size used for the test set (i.e., how many devices were tested for performance, how many units of materials, etc.) is not specified.

Regarding data provenance, the testing would have been conducted by Spectra Medical Devices, Inc. or contractors they employed, likely in the US (given the company's address in Wilmington, Massachusetts). The data is retrospective in the sense that it was generated for the purpose of this 510(k) submission, not from a prospective clinical trial on human subjects. The type of data is primarily in vitro and bench testing data to demonstrate compliance with standards and equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable in this context. The "ground truth" for a medical device like an introducer needle in a 510(k) submission is established by engineering specifications, material standards, and comparisons to legally marketed predicate devices, not by expert consensus on clinical findings. Performance is measured against physical and chemical parameters, not against interpretations of medical images or patient outcomes by experts.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human expert assessment of data (e.g., radiology reads). In the context of a 510(k) for an introducer needle, "adjudication" is not a standard part of the device's technical performance testing. Device performance is determined by meeting pre-defined physical and material specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical data, often with AI assistance. The Spectra Guidewire Introducer Needle is a physical surgical instrument, not a diagnostic imaging device or an AI algorithm intended to assist human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not applicable. The Spectra Guidewire Introducer Needle is a physical medical device, not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used

For this device, the "ground truth" for performance assessment is primarily based on:

Established engineering specifications and material standards: These define what constitutes acceptable strength, biocompatibility, sterility, dimensions, etc. (e.g., ISO 11135, ISO 10993).
Performance characteristics of predicate devices: The "ground truth" for equivalency is that the new device performs similarly to legally marketed devices that have already been deemed safe and effective. This is assessed via various physical and chemical bench tests (e.g., material compatibility, physical dimensions, functional tests implicitly covered by "design, materials, and method of use").

There is no "pathology" or "outcomes data" ground truth in the context of this 510(k) submission to demonstrate substantial equivalence of a guidewire introducer needle. Clinical outcomes would typically be part of a PMA (Premarket Approval) submission for a novel, high-risk device.

8. The Sample Size for the Training Set

This is not applicable. A "training set" refers to data used to train an algorithm or AI model. As established, this device is a physical medical instrument, not a software or AI product.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as point 8.

Summary

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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:

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: (978) 657-0889 Fax: (978) 657-4339 Email: aturriza@SpectraMedical.com

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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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