The SpineView ENSPIRE™ Debrider is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.

Device Description

The SpineView ENSPIRE™ Debrider is a single-use discectomy device that is designed to cut and grind intervertebral disc material. Its auger mechaeo mechaeo um retrieves the excised debris and ejects it into a collection chamber.

AI/ML Overview

The provided documentation for K090278, the ENSPIRE™ Debrider System, describes the device's intended use and comparison to predicate devices, along with a summary of supporting data. However, it does not include specific acceptance criteria, a detailed study design with sample sizes for test or training sets, information about ground truth establishment (other than general biocompatibility and bench testing), or specifics about expert involvement or adjudication methods typically found in AI/ML device studies.

This is because the ENSPIRE™ Debrider System is a physical medical device (a surgical tool for discectomy), not an AI/ML software device. Therefore, the types of studies and acceptance criteria applicable to AI/ML would not be relevant in this context. The evaluation focuses on physical characteristics, mechanical performance, biocompatibility, and intended use as a surgical instrument.

Here's a breakdown of what can be extracted from the document, tailored as much as possible to the requested format, while acknowledging the inherent differences for a non-AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance

As this is not an AI/ML device, there are no "acceptance criteria" in the traditional sense of performance metrics like sensitivity, specificity, or AUC for an algorithm. Rather, performance is assessed through compliance with standards and demonstrating functionality.

Acceptance Criteria (Implied from testing)	Reported Device Performance
Biocompatibility: Device materials are safe for human contact.	Biocompatibility testing demonstrates that the device is in compliance with ISO 10993. (This implies it met the criteria set forth in ISO 10993 for relevant biological effects.)
Bench Testing: Device functions as intended in a controlled environment and meets relevant standards/expectations for mechanical and operational performance.	Bench testing has demonstrated that the device is in compliance with the pertinent standards, the expectations of the medical community and the product labeling. (This implies that the device successfully met predefined standards and functional requirements for cutting, grinding, and aspirating intervertebral disc material, likely including aspects like cutting efficiency, aspiration rate, structural integrity, etc.)
Cadaver Testing: Device can be used safely and effectively as intended in a representative human anatomical model.	Cadaver testing demonstrated that the device can be used as intended in humans. (This suggests that the device was able to successfully perform discectomy procedures on cadaveric spines, allowing for assessment of handling, effectiveness in removing disc material, and absence of obvious design flaws in a more realistic setting.)
Substantial Equivalence: Device is as safe and effective as predicate devices.	The device is found substantially equivalent in intended use and technology to the predicate devices (Stryker Dekompressor and SpineVu Endoscopic Spine System). This determination by the FDA is the ultimate "acceptance" criteria for 510(k) clearance.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated.
- Biocompatibility: ISO 10993 testing involves specific material samples and biological models, but exact numbers or types of tests are not given.
- Bench Testing: Would involve multiple units of the device tested against various parameters, but specific sample sizes are not provided.
- Cadaver Testing: The number of cadavers or spinal levels used is not specified.
Data Provenance:
- The testing was conducted by SpineView, Inc., likely at their facilities or through contracted laboratories.
- The data would originate from laboratory and cadaver studies, not from patient data in the typical sense of AI/ML studies (retrospective or prospective patient cohorts).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts & Qualifications: Not specified in the provided text.
- For biocompatibility, experts would be toxicologists and material scientists.
- For bench testing, engineers and quality assurance personnel would evaluate performance against specifications.
- For cadaver testing, it would likely involve surgeons or medical professionals familiar with discectomy procedures, but the number and qualifications are not detailed.

4. Adjudication method for the test set

Adjudication Method: Not applicable or not specified. Decisions in non-AI/ML device testing are typically based on objective measurements against pre-defined specifications and regulatory standards, rather than expert consensus on subjective interpretations. For cadaveric studies, observations by attending surgeons would guide the assessment.

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

This question is Not Applicable as the ENSPIRE™ Debrider System is a physical surgical device, not an AI/ML diagnostic or assistive software. There are no "human readers" or "AI assistance" in this context.

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

This question is Not Applicable as the ENSPIRE™ Debrider System is a physical surgical device and does not involve an algorithm.

7. The type of ground truth used

Type of Ground Truth:
- Biocompatibility: Established through standardized tests against biological endpoints as defined by ISO 10993. The "ground truth" is that the material either passes or fails these established biological safety criteria.
- Bench Testing: Engineering specifications and relevant industry standards serve as the "ground truth" for mechanical and functional performance (e.g., a certain cutting force must be achieved, or aspiration rate met).
- Cadaver Testing: The ability of the device to effectively cut, grind, and aspirate disc material in an anatomical setting, without causing unforeseen damage or encountering significant operational difficulties. The "ground truth" is whether the device performed its intended function successfully and safely in the simulated surgical environment.
- Substantial Equivalence: The performance and characteristics of the predicate devices serve as the "ground truth" for comparison.

8. The sample size for the training set

This question is Not Applicable as the ENSPIRE™ Debrider System is a physical device and does not involve AI/ML requiring a training set.

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

This question is Not Applicable for the same reason mentioned above.

Summary

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K090278

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SpineView, Inc.

APR 1 5 2009 ENSPIRE™ Debrider System Traditional 510(k) Premarket Notification

Section 5: 510(k) Summary

Device Information:

Category	Comments
Sponsor:	Spine View, Inc.48541-Warm Springs Blvd., Suite 507Fremont, CA 94539
Correspondent ContactInformation:	Sandra SundellDirector, Regulatory AffairsSpineView, Inc.48541 Warm Springs Blvd., Suite 507Fremont, CA 94539Tel: 510 585-5345Fax: 510 623-1093Email:ssundell@spineview.com
Device Common Name:	Arthroscope and Accessories
Device Classification &Code:	Arthroscope: Class II, HRXArthroscope Accessories: Class I, NBH
Device ClassificationName:	21 CFR § 888.1100 Arthroscope andAccessories
Device Proprietary Name:	ENSPIRE™ Debrider System

Predicate Device Information:

Predicate Devices:	Stryker DekompressorPercutaneous DiscectomyProbe	SpineVu Endoscopic SpineSystem (SESS)
Predicate DeviceManufacturers:	Stryker Instruments	SpineView, Inc.
K#s	K032473	K081051
Predicate Device CommonName:	Percutaneous DiscectomyProbe ArthroscopicIntervention Kit	Arthroscopic Intervention Kit
Predicate DeviceClassification:	21CFR888.1100:Arthroscope & Accessories	21CFR888.1100: Arthroscope& Accessories
Predicate DeviceClassification & Code:	Class II, HRX	Class II, HRX

b. Date Summary Prepared

February 3, 2009

Description of Device C.

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SpineView, Inc.

d. Intended Use

The SpineView ENSPIRE™ Debrider is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.

e. Comparison to Predicate Device

The SpineView ENSPIRE™ Debrider is substantially equivalent in intended use and technology to the currently marketed predicate devices the Debrider component of the SpineVu Endoscopic Spine System (K081051) and the Stryker Dekompressor Percutaneous Discectomy Probe (K032473). Both the Application device and the predicate devices provide a means to aspirate and grind disc material during discectomies in the lumbar, thoracic and cervical regions of the spine. The SpineView ENSPIRE™ Debrider and the predicate devices are all intended to be used to cut and remove diseased disc material in the same anatomical location.

f. Summary of Supporting Data

Biocompatibility testing demonstrates that the device is in compliance with ISO 10993.

Bench testing has demonstrated that the device is in compliance with the pertinent standards, the expectations of the medical community and the product labeling.

Cadaver testing demonstrated that the device can be used as intended in humans.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spine View, Inc. % Ms. Sandra Sundell Director, Regulatory Affairs 48541 Warm Springs Boulevard Suite 507 Fremont, California 94539

APR 1 5 2009

Re: K090278

Trade/Device Name: ENSPIRE™ Debrider System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Product Code: HRX Dated: March 23, 2009 Received: March 24, 2009

Dear Ms. Sundell:

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.

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

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

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Page 2 - Ms. Sandra Sundell

(240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

for Don Rim

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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SpineView, Inc.

Section 4: Indications for Use Statement

510(k) Number (if known):

Device Name: ENSPIRE™ Debrider System

Indications For Use: The SpineView ENSPIRE™ Debrider is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.

Prescription Use X (Part 21 CFR 801 Subpart D) 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)

Neil R.R. Oglesby L.r.m.x.m

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

AND/OR

510(k) Number K090278

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.