The enSpire™ Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectorny procedures in the cervical, thoracic and lumbar spine.

Device Description

The modified enSpire™ Discectomy System is a single-use discectomy device that is designed to cut and grind intervertebral disc material. An auger mechanism retrieves the excised debris and ejects it into a collection chamber. The modified enSpire™ Discectorny System is supplied as a sterile, single patient use, disposable device.

AI/ML Overview

The provided text describes a 510(k) submission for the enSpire™ Discectomy System, a medical device for discectomy procedures. It focuses on demonstrating substantial equivalence to a predicate device and outlines non-clinical testing performed.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it lists the types of non-clinical (bench) tests performed and makes a general statement about their success.

Acceptance Criteria (Implied)	Reported Device Performance
Functional/Mechanical Performance:
Cannula Compatibility	"Results of the pre-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the modified enSpire™ Discectomy System meet the established specifications necessary for consistent performance during its intended use." Additionally, "non-clinical testing was conducted to validate the performance of the device and ensure the modified enSpire™ Discectomy System performs as intended and meets the design specifications."
Enable Switch Durability	Same as above.
Deployment & Retraction	Same as above.
Working Shaft Length	Same as above.
Device Durability	Same as above.
Travel Limiter Attachment	Same as above.
Travel Limiter	Same as above.
Tensile Strength	Same as above.
Articulation Function	Same as above.
Articulation Angle	Same as above.
Tissue Volume/Material Removal	"No Breach of Annulus or Endplates" (specifically for this test), and generally, "meet the established specifications necessary for consistent performance during its intended use."
No Breach of Annulus or Endplates (during material removal)	"No Breach of Annulus or Endplates"
Safety/Biocompatibility/Sterilization:
Visualization	Same as functional/mechanical performance.
Peak Temperature during Operation	Same as functional/mechanical performance.
Electromagnetic Compatibility and Electrical Safety	Same as functional/mechanical performance.
Packaging Testing	Same as functional/mechanical performance.
Shipping Testing	Same as functional/mechanical performance.
Sterility Testing	Same as functional/mechanical performance.
Shelf Life Testing	Same as functional/mechanical performance.
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity)	"Biocompatible for Intended Use: Yes" (in comparison table to predicate) and generally, "meet the established specifications necessary for consistent performance during its intended use."

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

The document does not specify the sample size for any of the non-clinical tests conducted. It also does not mention the country of origin of the data or whether the tests were retrospective or prospective, as these are in-vitro bench studies.

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)

This information is not applicable and not provided. The testing described is non-clinical (bench testing) and does not involve human subjects or expert assessment for ground truth determination in the typical sense of a clinical study.

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

This information is not applicable and not provided, as the studies are non-clinical bench tests, not clinical studies requiring adjudication of outcomes or diagnoses.

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

No such study was performed or mentioned. The device is a surgical discectomy system, not an AI-assisted diagnostic tool requiring MRMC studies.

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

This information is not applicable. The device is a mechanical surgical tool, not an algorithm.

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

For the non-clinical bench studies, the "ground truth" would be established by the design specifications and engineering requirements of the device. For example, for "Tensile Strength," the ground truth would be a defined tensile strength threshold. For "No Breach of Annulus or Endplates," the ground truth is the absence of such breaches, directly observed during the in-vitro tissue volume removal testing.

8. The sample size for the training set

This information is not applicable and not provided. The device described is a mechanical surgical tool, not an AI/ML algorithm that requires a training set.

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

This information is not applicable and not provided, as there is no training set for this device.

Summary

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510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

A. Name, Address, Phone and Fax Number of Applicant

K120680

Spine View, Inc. 48810 Kato Road, Suite 100E Fremont, CA 94538 Phone: (510) 623-1931 (510) 490-1753 Fax:

B. Contact Person

Diana DeGregorio Lincé Consulting Regulatory Affairs Consultant (925) 980-8047 dianadegregorio@comcast.net

Alternate Contact: Mbithi Muthini Director Quality and Regulatory (510) 743-5090 mmuthini@spineview.com

C. Date Prepared

March 5, 2012

D. Device Name

Trade Name: enSpire™ Discectomy System Common Name: Arthroscope & Accessory Classification Name: Arthroscope & Accessories (21 CFR §888.1100, Product Code HRX)

E. Predicate Devices

The modified enSpire™ Discectomy System is substantially equivalent to the Spine View enSpire™ Discectomy System cleared under K110992 on October 21, 2011.

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Spine View, Inc.

F. Device Description

The modified enSpire™ Discectorny System is supplied as a sterile, single patient use, disposable device.

G. Intended Use

The modified enSpire™ Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectorny procedures in the cervical, thoracic and fumbar spine.

H. Technological Comparison

The modified enSpire™ Discectorny System has similar features compared to the predicate devices in the table below.

Manufacturer	Spine View, Inc.	Spine View, Inc.
Device Name	enSpire™ Discectomy System	Modified enSpire™ Discectomy System
510(k) Number	K110992	TBD
Indications for Use	The enSpire™ Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectomy procedures in the cervical, thoracic and lumbar spine.	Same
Product Code	HRXArthroscope, 21CFR888.1100, Class II, (Debrider)	Same
Principal Operator	Physician	Same
Use Location	Operating Room or Medical Suite	Same
Operating Principal	Percutaneous, endoscopic or open surgical Discectomy system with standard surgical accessories	Same
Functions of Included Devices	DilatationAccessExcisionAspiration	Same
Mechanics of Action	Activating the device causes the cutting mechanism to expand and rotate and auger to rotate to cut and grind the disc material, which is then aspirated down the working shaft of the device and collected in the collection chamber	Activating the device causes the auger to rotate against the entrapped tissue and fixed cutting mechanism to cut and grind the disc material, which is then aspirated down the working shaft of the device and collected in the collection chamber
Target Anatomy	Cervical, Thoracic and Lumbar spinal segments	Same
Design Features	Auger housed in a tube with expandable rotating cutting assembly (spiral wire or curette style cutter) on the distal end. Driven by a battery-powered motor that is housed in a plastic handle at the proximal end of the device.	Auger housed in a tube with a non-expandable Serrated Cutting Window at the distal end. Driven by a battery-powered motor that is housed in a plastic handle at the proximal end of the device.
Manufacturer	Spine View, Inc.	Spine View, Inc.
Device Name	enSpire™ Discectomy System	Modified enSpire™ Discectomy System,
510(k) Number	K110992 device.	TBD
	Cut debris can pass up the tube and into thecollection chamber located at the end of theauger. It is inserted into the surgical siteeither directly, via an introducer cannula orArthroscope.	Cut debris can pass up the tube and into thecollection chamber located at the end of theauger. It is inserted into the surgical siteeither directly, via an introducer cannula orArthroscope.
	The device contains a straight, curved orarticulating working shaft.	The device contains a straight or articulatingworking shaft.
	Expandable spiral wire and a curette stylecutterSweep Diameter (Expanded): 0.280 - 0.390"	Non-Expandable Serrated Cutting WindowsSV3309: 0.075" x 0.240" x 2 windowsSV1107: 0.055" x 0.170" x 2 windows
Tip Materials	PEEK, Aramid Fiber, Polyimide, StainlessSteel, and Tungsten	Stainless Steel
Sterile Packaging	The enSpire™ Discectomy System is placedinto a thermo formed tray with athermoformed insert lid, and sealed with aTyvek tray lid. The sealed tray is then placedin a labeled chip board shelf carton.	Same
Sterilization Method	Gamma	Same
Biocompatible forIntended Use	Yes	Yes
Single use	Yes	Yes
Configuration	Straight, Curved, Articulating	Straight or Articulating
Handle Design	Hand-held rotary device, in-line or pistol-griphandle	Same
Profile	0.046-0.165" OD working shaft with tip0.280-0.400" OD deployed, 0.058-0.220" ODunexpanded	0.058-0.110" OD shaft diameter at tip
Working Length	2 -22" working length	2 -9" working length
Energy Type	Mechanical	Same
Power	Battery, 9V or 18V	Same
Meets ApplicableIEC60601-1 testing	Yes	Yes
User visualization/guidance	Direct visualization, fluoroscopic imaging orother imaging modalities	Same

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Spine View, Inc.

K120680

The technological characteristics and principals of operation of the modified enSpire™ Discectomy System are substantially equivalent to the named predicate device.

i. Summary of Non-Clinical Data

The modified enSpire™ Discectomy System performance characteristics were evaluated in the following in-vitro bench studies:

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K120680

Cannula Compatibility .
. Enable Switch Durability
. Deployment & Retraction
Working Shaft Length .
Device Durability .
Travel Limiter Attachment .
Travel Limiter .
Tensile Strength .
Articulation Function .
. Articulation Angle
. Visualization
Peak Temperature during . Operation
· Electromagnetic Compatibility and Electrical Safety
· Packaging Testing
· Shipping Testing
· Sterility Testing
· Shelf Life Testing
· Biocompatibility:
- Cytotoxicity ం
- Sensitization o
- Irritation O
- Systemic Toxicity o
Tissue Volume/Material Removal . No Breach of Annulus or Endplates

Results of the pre-clinical testing demonstrate that the materials chosen, the manufacturing process, and design of the modified enSpire™ Discectomy System meet the established specifications necessary for consistent performance during its intended use. In addition, the testing demonstrates the modified enSpire™ Discectomy System is substantially equivalent to the named predicate.

J. Summary of Data

The modified enSpire™ Discectomy System has been carefully compared to a legally marketed device with respect to intended use and technological characteristics. In addition, non-clinical testing was conducted to validate the performance of the device and ensure the modified enSpire™ Discectomy System performs as intended and meets the design specifications. The non-clinical performance testing and comparison to the predicate device demonstrate that the modified enSpire™ Discectomy System is substantially equivalent to the predicate device and does not raise new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Spine View, Incorporated % Ms. Diana DeGregorio Regulatory Affairs Consultant 48810 Kato Road Suite 100E Fremont, California 94538

Re: K120680

Trade/Device Name: enSpire™ Discectomy System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope & Accessory Regulatory Class: Class II Product Code: HRX Dated: June 15, 2012 Received: June 18, 2012

Dear Ms. DeGregorio:

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

JUN 2 6 2012

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Page 2 - Ms. Diana DeGregorio

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for Math Dar
or

Mark N. Melke Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K_K12 06 80

Device Name:

enSpire™ Discectomy System

Indications for Use:

The enSpire™ Discectomy System is intended for use in cutting, grinding and aspirating intervertebral disc material during discectorny procedures in the cervical, thoracic and lumbar spine.

Prescription Use × OR

Over-The-Counter Use

(per 21 CFR 801.109)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Niel R.P. Ogden for mkn

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

. 510(k) Number K120680

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.