The Light Sabre™ Spinal Access Device is a single-use disposable device that is used to obtain biopsies of bone and/or bone marrow and is used to provide a port of entry to place guidewires during percutaneous spinal procedures. The device will consist of a stainless steel stylet with an attached plastic hub that will fit into a stainless steel cannula that has an attached plastic hub. A removable handle will also be provided with the device. The Light Sabre™ Spinal Access Device is designed to work with the MINRAD SabreSource™ Targeting System, as accepted for market under K022935. To do this, the Light Sabre™ Spinal Access Device incorporates a collimating channel and light-dispersing element directly into the stylet assembly. When the Light Sabre™ Spinal Access Device is aligned with the laser beam of the SabreSource™ Targeting System, the laser will clearly illuminate the light-dispersing element. Whenever the device is moved out of the path, as defined by the laser beam, the light-dispersing element of the Light Sabre™ Spinal Access Device ceases to glow.

AI/ML Overview

The provided 510(k) summary for the Light Sabre™ Spinal Access Device does not contain specific acceptance criteria or a detailed study proving the device meets performance criteria in the way typically discussed for AI/ML-based medical devices. This document describes a medical device (biopsy needle) and focuses on substantial equivalence to a predicate device, manufacturing standards, and biological safety.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission.

Here's a breakdown of what can be derived from the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" or provide performance metrics in quantitative terms for the device's function (e.g., biopsy success rate, accuracy of guidewire placement). Instead, it relies on demonstrating compliance with recognized standards and substantial equivalence to a predicate device.

Acceptance Criteria Category	Reported Device Performance / Compliance
Material Biocompatibility	All materials used will be evaluated through biological qualification safety tests as outlined in applicable sections of ISO 10993. (Implies meeting biocompatibility requirements of ISO 10993, but no specific pass/fail rates or test results are provided in this summary.)
Manufacturing Standards	Will be manufactured in accordance with the following standards (implies compliance with these standards): 1. ASTM F1140-00 2. ANSI/AAMI/ISO 11137:1994 3. ANSI/AAMI/ISO 11737-1:1995 4. AAMI TIR 17:19975. AAMI TIR 27:20016. ANSI/AAMI/ISO TIR 15843:20007. ANSI/AAMI ST 72:20028. ASTM D-5276-98(2004)9. ASTM F88-0610. ISO 1160711. ISO 9626:199112. ISO 594:198613. ISO 10993-1:200314. ISO 10993-5:199915. ISO 10993-10:2002
Sterility	Provided sterile for single use (Implies meeting sterility requirements, likely dictated by ANSI/AAMI/ISO 11137:1994 and related standards).
Mechanical Features	Needle Length: 10 - 15cm Needle Gauge/Diameter: 8, 11, 13 Gauge Stainless Steel Material: Stainless Steel 304 Stylet/Cannula Hub Material: Gamma Stable Polycarbonate Includes method to remove biopsy sample: Included in Packaging is Core Sampler made of Stainless Steel 304 Able to connect Syringe for Aspiration or Injection: Luer Lock per ISO 594-2:1998 (E) on Luer Adapter Component
Substantial Equivalence	Considered substantially equivalent to the Light Sabre™ Bone Biopsy Needle (K982735).
Laser Targeting Integration	Integrates a collimating channel and light-dispersing element into the stylet assembly to work with the MINRAD SabreSource™ Targeting System (K022935). (Implies functional compatibility with the targeting system).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not describe a "test set" in the context of clinical performance data for an AI/ML device. The testing mentioned refers to material qualification and compliance with industry standards, not a clinical study on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no mention of a clinical test set requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (biopsy needle), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this device would relate to its physical properties, sterility, and biocompatibility, which are assessed through laboratory tests against established standards, not clinical ground truth like pathology for a diagnostic device.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" as it is not an AI/ML product.

9. How the ground truth for the training set was established

Not applicable.

Summary

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PREMARKET NOTIFICATION 510(k)

Ko71814

5.0	510(k) Summary or 510(k) Statement
	MINRAD
		510(k) Summary
1.	510(k) owner's name:	Minrad, Inc.
2.	Address:	50 Cobham DriveOrchard Park, NY 14127Phone: (716) 855-1068Facsimile: (716) 855-1078
	Contact:	John McNeirney,Senior Vice President & Chief Technical Officer
3.	Preparation Date:	June 29, 2007
4.	Device name:	Light Sabre™ Spinal Access Device
5.	Common name:	Biopsy Needle
6.	Product classification:	Instrument, Biopsy (21 CFR 876.1075, Product Code KNW)
7.	Predicate device:	Light Sabre™ Bone Biopsy Needle (K982735)
8.	Description of device:	The Light Sabre™ Spinal Access Device is a single-use disposable device that is used to obtain biopsies of bone and/or bone marrow and is used to provide a port of entry to place guidewires during percutaneous spinal procedures. The device will consist of a stainless steel stylet with an attached plastic hub that will fit into a stainless steel cannula that has an attached plastic hub. A removable handle will also be provided with the device. The Light Sabre™ Spinal Access Device is designed to work with the MINRAD SabreSource™ Targeting System, as accepted for market
	Minrad, Inc.50 Cobham Drive	12 of 45

50 Cobham Drive Orchard Park, NY 14127

CONFIDENTIAL

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PREMARKET NOTIFICATION 510(k)

	under K022935. To do this, the Light Sabre™ SpinalAccess Device incorporates a collimating channel andlight-dispersing element directly into the stylet assembly.When the Light Sabre™ Spinal Access Device is alignedwith the laser beam of the SabreSource™ TargetingSystem, the laser will clearly illuminate the light-dispersing element. Whenever the device is moved out ofthe path, as defined by the laser beam, the light-dispersing element of the Light Sabre™ Spinal AccessDevice ceases to glow.
9.Voluntarystandards:	There are not any specific standards promulgated but theLight Sabre™ Spinal Access Device will bemanufactured in accordance with following standards:1. ASTM F1140-002. ANSI/AAMI/ISO 11137:19943. ANSI/AAMI/ISO 11737-1:19954. AAMI TIR 17:19975. AAMI TIR 27:20016. ANSI/AAMI/ISO TIR 15843:20007. ANSI/AAMI ST 72:20028. ASTM D-5276-98(2004)9. ASTM F88-0610. ISO 1160711. ISO 9626:199112. ISO 594:198613. ISO 10993-1:200314. ISO 10993-5:199915. ISO 10993-10:2002
10. Intended use andindication for use:	The Light Sabre™ Spinal Access Device is a single-usedisposable device that is used to obtain biopsies of boneand/or bone marrow and is used to provide a port of entryto place guidewires during percutaneous spinalprocedures.
11.Technologicalcharacteristics:	Indications for Use: A single-use disposable device thatis used to obtain biopsies of bone and/or bone marrowand is used to provide a port of entry to place guidewiresduring percutaneous spinal procedures.Sterility: Provided sterile for single useNeedle Type: Cannula - Stainless Steel with Plastic HubAssembly; Stylet - Stainless Steel with Plastic HubAssembly
Needle Length: 10 - 15cm
Needle Gauge/Diameter: 8, 11, 13 Gauge
Stainless Steel Material: Stainless Steel 304
Stylet/Cannula Hub Material: Gamma Stable
Polycarbonate
Method of Sterilization: Gamma Radiation
Includes method to remove biopsy sample: Included
in Packaging is Core Sampler made of Stainless Steel
304
Able to connect Syringe for Aspiration or Injection:
Luer Lock per ISO 594-2:1998 (E) on Luer Adapter
Component
12.	Testing	All materials used in the fabrication of the Light Sabre™Spinal Access Device will be evaluated throughbiological qualification safety tests as outlined in theapplicable sections of ISO 10993. These materials willalso be tested in accordance with industry recognized testmethods that are applicable based on the intended use ofthe device.

50 Cobham Drive Orchard Park, NY 14127 of 45

CONFIDENTIAL

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PREMARKET NOTIFICATION 510(k)

This concludes the 510(k) summary.

Minrad, Inc. 50 Cobham Drive Orchard Park, NY 14127

. .

CONFIDENTIAL

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three overlapping profiles facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.

OCT 1 6 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Minrad, Inc. % Mr. John McNeirney Senior VP and Chief Technical Officer 50 Cobham Drive Orchard Park, New York 14127

Re: K071814

Trade/Device Name: Light Sabre™ Spinal Access Device Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: KNW Dated: August 30, 2007 Received: September 7, 2007

Dear Mr. McNeirney:

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.

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.

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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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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PREMARKET NOTIFICATION 510(k)

Indications for Use Statement 4.0

510(k) Number (if known):

Device Name: Light Sabre™ Spinal Access Device

Indications for Use:

Prescription Use X Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use (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)

Division Sign-Division of General, Restorative, nd Neurological Devices

Number 1671814

Minrad, Inc. 50 Cobham Drive Orchard Park, NY 14127 11 of 45

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Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.