The Ultrazonix Spine Minimal-Invasive Disc System is intended for use by professional medical personnel for coagulation and decompression of intervertebral disc material to treat symptomatic patients with annular disruption of contained herniated lumbar discs. The safety and efficacy of this device has not been established in the thoraci and cervical intervertebral regions of the spine and should not be used in those negions. The Ultrazonix Spine Minimal-Invasive Disc System is comprised of a non-disposable Control Unit, and a sterile, single-use Probe Kit. These two major component parts are described as follows: a) Non disposable Control Unit This contains a power supply, a high frequency-generator, an amplifier, an independent safety system and a user interface with an alphanumerical display and a key pad and a foot-operated switch. The probe and a foot-operated switch are connected to the Control Unit. High frequency induced ultrasound is emitted from the probe and controlled by means of the foot-operated switch. b) Sterile, single-use Probe Kit, consisting of A blunt 500 mm long stainless steel Guide Pin with a diameter of 2 mm. The Guide Pin is used as a pathfinder to navigate towards the spinal disk under fluoroscopic guidance. A 5.3 mm Dilator which is used to prepare a canal for the Introducer. It has a conical front which ensures as little harm as possible is done to adjacent tissue and blood vessels A 6 mm Introducer which is a thin walled, approximately 180 mm long tube with a handle to be used as a guide for the Probe. It is placed over the Dilator and when the desired position against the disk is reached the Guide Pin and the Dilator are removed and The ultrasonic Probe is inserted into the Introducer. It consists of a thin shaft with a piezo ceramic transducer placed at the front /tip.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Ultrazonix Spine Minimal-Invasive Disc System.

Here's an analysis of the acceptance criteria and study information based on the provided document:

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

The document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics for the device’s efficacy (e.g., a certain percentage of disc decompression or coagulation effectiveness). Instead, the acceptance is based on demonstrating "substantial equivalence" to predicate devices. The performance data section refers to "in vitro and animal study evaluations" and "current clinical experiences" showing the device "functions as intended" and is "safe and efficient in coagulation and decompression of disc tissue."

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Devices: The device must be demonstrated to be equally safe and effective as legally marketed predicate devices, specifically the Oratec SpineCATH / ORA-50S Auto Temp Electro Thermal Spine System. This implies similar indications for use and technological characteristics.	- In vitro and animal study evaluations: Showed the Ultrazonix Spine Minimal-Invasive Disc System "functions as intended."- Sufficiency of pre-clinical data: Data gathered was deemed "sufficient" to qualify the system as "safe and efficient in coagulation and decompression of disc tissue."- Current clinical experiences: Also showed the product is "safe in coagulation and decompression of lumbar discs."- Technological Characteristics: The device is considered "the same" as the predicate for coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated lumbar discs. Any differences "do not raise new questions of safety and effectiveness."

Acceptance Criteria

Reported Device Performance

Substantial Equivalence to Predicate Devices: The device must be demonstrated to be equally safe and effective as legally marketed predicate devices, specifically the Oratec SpineCATH / ORA-50S Auto Temp Electro Thermal Spine System. This implies similar indications for use and technological characteristics.

- In vitro and animal study evaluations: Showed the Ultrazonix Spine Minimal-Invasive Disc System "functions as intended."- Sufficiency of pre-clinical data: Data gathered was deemed "sufficient" to qualify the system as "safe and efficient in coagulation and decompression of disc tissue."- Current clinical experiences: Also showed the product is "safe in coagulation and decompression of lumbar discs."- Technological Characteristics: The device is considered "the same" as the predicate for coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated lumbar discs. Any differences "do not raise new questions of safety and effectiveness."

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

The document does not provide details on the sample size for human test subjects or the provenance (country, retrospective/prospective nature) of the "current clinical experiences" mentioned. It only refers to "in vitro and animal study evaluations" and "current clinical experiences."

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 provided in the document. The type of study described (pre-clinical and clinical experience for safety and efficacy) does not typically involve independent experts establishing ground truth in the same way an AI diagnostic device study would.

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

This information is not provided in the document.

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

This was not an AI diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers' improvement with AI assistance would not be applicable, and no such study is mentioned. The device described is a surgical tool.

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

This was not an AI diagnostic device, so a standalone algorithm performance study is not applicable. The device itself is a standalone medical tool for performing a procedure, and its performance was assessed through in vitro, animal, and clinical experiences.

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

The document implicitly uses physiological outcomes (demonstrated coagulation and decompression of disc tissue) and patient safety and efficacy from "current clinical experiences" as the ground truth indicators. The "in vitro and animal study evaluations" would also assess direct physical effects of the device on tissue.

8. The sample size for the training set

This is not an AI/ML device, so there is no "training set." The device's design and operational parameters would be developed through engineering and experimental testing, not machine learning training.

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

As it is not an AI/ML device, there is no training set or ground truth established for one.

Summary

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510(k) Notification Supplement K060346-Ultrazonix Spine Minimal-Invasive Disc System December 19, 2006

510(K) Notification SUMMARY

KOGO346

SUBMITTER:

Ultrazonix DNT AB Krossverksgatan 3 SE-216 16 Malmo Sweden

DEC 2 2 2006

DATE PREPARED:

December 19th , 2006

DEVICE NAME:

Ultrazonix Spine Minimal-Invasive Disc System

CLASSIFICATION NAME:

Electrosurgical cutting and coagulation device and accessories

PREDICATE DEVICES:

Oratec SpineCATH, Orateac ORA-50S Auto Temp Electro Thermal Spine System, and Epicor Medical UltraCinch Tissue Ablation Device & Accessories

Device Description:

a) Non disposable Control Unit

This contains a power supply, a high frequency-generator, an amplifier, an independent safety system and a user interface with an alphanumerical display and a key pad and a foot-operated switch. The probe and a foot-operated switch are connected to the Control Unit. High frequency induced ultrasound is emitted from the probe and controlled by means of the foot-operated switch.

b) Sterile, single-use Probe Kit, consisting of

A blunt 500 mm long stainless steel Guide Pin with a diameter of 2 mm. The Guide Pin is used as a pathfinder to navigate towards the spinal disk under fluoroscopic guidance.

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A 5.3 mm Dilator which is used to prepare a canal for the Introducer. It has a conical front which ensures as little harm as possible is done to adjacent tissue and blood vessels

A 6 mm Introducer which is a thin walled, approximately 180 mm long tube with a handle to be used as a guide for the Probe. It is placed over the Dilator and when the desired position against the disk is reached the Guide Pin and the Dilator are removed and

The ultrasonic Probe is inserted into the Introducer. It consists of a thin shaft with a piezo ceramic transducer placed at the front /tip.

Predicate Devices:

There has been a device previously cleared by the FDA in the following 510(K) Notification indicated for use for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.

Device	510(k) Document Number	Date Cleared	Indications
Oratec SpineCATHIntradiscal Catheter&Oratec ORA-50 SAuto Temp ElectroThermal SpineSystem &Accessories	K974464 K993854	3/19/199812/6/1999	coagulation anddecompression of discmaterial to treatsymptomatic patientswith annulardisruption ofcontained herniateddiscs
Epicor MedicalUltraCinch TissueAblation Device andAccessories	K040641	5/5/2004	For the ablation ofcardiac tissue duringcardiac Surgery

Table 6. Predicate Device(s)

Technologically, both the proposed and predicate devices are substantially equivalent. Both proposed and predicate devices are electrosurgical devices which are indicated for use for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained lumbar herniated discs. Both the proposed and predicate devices utilize heat generated at the tip of the catheter / probe to deliver thermal

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510(k) Notification Supplement K060346-Ultrazonix Spine Minimal-Invasive Disc System December 19, 2006

energy to the tissue. Both also utilize a radiopaque marking at the proximal end of the catheter/probe to position the catheter/probe under fluoroscopy. Any differences between the two devices do not raise new questions of safety and effectiveness.

Intended Use:

Ultrazonix Spine Minimal-Invasive Disc System Indications:

Technological Characteristics:

Technologically, both the new device and the predicate device are the same (i.e. both are intended for use for the coagulation and decompression of lumbar disc material to treat symptomatic patients with annular disruption of contained lumbar herniated discs). Any differences between the two devices do not raise new questions of safety and effectiveness

Performance Data:

Results of in vitro and animal study evaluations show that the Ultrazonix Spine Minimal-Invasive Disc System functions as intended. Sufficient pre-clinical data has been gathered to qualify that the system is safe and efficient in coagulation and decompression of disc tissue. Current clinical experiences also show that the product is safe in coagulation and decompression of lumbar discs.

Conclusions:

Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the modified device is substantially equivalent to the existing legally marketed device under the Federal Food, Drug and Cosmetic Act.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features an eagle with its wings spread, clutching a caduceus in its talons. 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

Ultrazonix DNT AB % International Medical Products Corp. Jeffrey R. Shideman, Ph.D. President 7307 Glouchester Drive Edina, Minnesota 55435

DEC 2 2 2 2006

Re: K060346

Trade/Device Name: Ultrazonix Spine Minimal-Invasive Disc System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NTB Dated: October 18, 2006 Received: October 23, 2006

Dear Dr. Shideman:

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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Page 2 - Jeffrey R. Shideman, Ph.D.

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 vours.

Sincerely yours,

Barbara Buehrig

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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Indications for Use

510(k) Number (if known): K060346

Device Name: Ultrazonix Spine Minimal-Invasive Disc System

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

000052

currence of CDRH, Office of Device Evaluation (ODE)

Boubare Bruelo

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

Page 1 of 1

510(k) Number K060346

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.