DISSECTRON PORTABLE UNIT by SATELEC

The DISSECTRON is an ultrasonically vibrating hand-held surgical aspirator designed to precisely fragment and emulsify unwanted neurosurgical tissue, layer by layer, with preservation of major blood vessels, nerves, and elastic fibers. The DISSECTRON's selective effect on tissue is the result of three combined factors: Ultrasonic fragmentation, Irrigation, and, Suction. The DISSECTRON's principle of operation is tissular fragmentation which is achieved through uitrasonic longitudinal vibrations at an oscillation amplitude varying from 120 to 300um, at an operating frequency comprised between 23 and 35 kHz at the tip of the handpiece. The ultrasonic power is transmitted via a piezoelectric transducer, housed in the handpiece, which extends into a titanium sonotrode which is in direct contact with the tissue. It is possible to precisely dissect tissue with less surrounding tissue invasion and blood loss with DISSECTRON. Simultaneous irrigation is provided to the distal end of the tip. Sterile saline is routed from the drip holder to the control unit to the tip of the electrostrictive handpiece. A vacuum pump aspirates emulsified tissue in the pressure range of 650 hPa. Irrigating fluid and fragmented tissue particles are continuously aspirated through the distal end of the hollow titanium sonotrode (tip) and transported, via disposable tubing, to a collection bottle ("receptacle"). The DISSECTRON, a compact, portable, tabletop ultrasonic surgical aspirator installed in the surgical suite within the user's reach, consists of three primary components: the base console, the hand-piece unit, (with 2 sonotrode dedicated extensions, and, the control pedal (footswitch). The base console is controlled by a microprocessor and provides various indicators and controls designed to lead the operator through the sequential procedures needed for safe operation. Touch screen controls and displays provide the surgeon with a user friendly device. The lightweight electrostrictive handpiece is equipped with a titanium sonotrode, which acts as an ultrasonic transmitter, and is fitted with central suction and concentric irrigation. The foot pedal has two footswitches, a right switch, and a left switch, respectively, to control the Suction, Irrigation, and Ultrasound power.

AI/ML Overview

This document is a 510(k) premarket notification for the "DISSECTRON" ultrasonic surgical aspirator. It focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and performance study details is not present in this document.

Here's an analysis of the provided text in relation to your request:

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

This information is not present in the provided document. The document describes the device and its intended use, and then lists predicate devices to which it claims substantial equivalence. It does not define specific performance acceptance criteria (e.g., fragmentation rate, blood loss reduction percentages, or specific tissue selectivity metrics) nor does it report the DISSECTRON's performance against such criteria through a dedicated study.

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

This information is not present. The document does not describe a performance study with a test set. It relies on a comparison to predicate devices, implying that their established performance serves as the benchmark for substantial equivalence.

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 present. As no specific performance study with a test set is described, there's no mention of experts establishing ground truth for such a set.

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

This information is not present. No test set or adjudication method is described.

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 information is not present and not applicable. The DISSECTRON is an ultrasonic surgical aspirator, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to human reading improvement with AI is irrelevant to this device.

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

This information is not present and not applicable. The DISSECTRON is a surgical device operated by a surgeon (human-in-the-loop). There is no "algorithm only" performance that would be separated from human operation in this context.

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

This information is not present. Since a dedicated performance study with a specified "ground truth" is not detailed, this information is absent. The basis for safety and effectiveness is largely substantial equivalence to legally marketed predicate devices, meaning the established safety and effectiveness of those devices serves as the de facto "ground truth" for the DISSECTRON, rather than a new de novo ground truth establishment.

8. The sample size for the training set

This information is not present. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

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

This information is not present. See point 8.

Summary of available information regarding substantiation (instead of an "acceptance criteria" study):

The document aims to demonstrate substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in a novel study.

Predicate Devices: The DISSECTRON is deemed substantially equivalent to:
- Cooper Cavitron CUSA 200M (K864943)
- Sharplan 4300/4310 (K883091)
- Clinical Technology BOVIE (K855138A)
Basis for Substantial Equivalence:
- Technical Characteristics: "The technical characteristics are almost identical to those of Cooper Cavitron CUSA 200 M, the Sharplan 4300/4310, and the Clinical Technology BOVIE previously cleared predicate devices." (Page 2)
- Differences: Differences in technical specifications, materials, physical appearance, and control systems "do not affect the relative safety or effectiveness of the DISSECTRON device." (Page 2)
- Intended Use: The intended use for the DISSECTRON is "for the successful fragmentation, emulsification and aspiration of soft tissue of various extirpation of any tumor in the central nervous system," which is consistent with the predicate devices. (Page 2) Specific indications are listed for neurosurgery, including various types of brain and spinal tumors. (Page 2)
- Exclusions: It is explicitly not intended for cardiac surgery, suction lipectomy, or orthopedics. (Page 3)

In essence, the "study" proving the device meets criteria is implicitly the regulatory review process that determined its substantial equivalence to already cleared devices based on a comparison of device specifications and intended use. The FDA letter confirms this determination, allowing the device to be marketed.

Summary

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OCT - 8 1997

Regulatory Affairs

K972612

SMDA Summary of Safety and Effectiveness - "510(k) Summary" 9.

A. Submittor Information
SATELEC Medical Z.I. due Phare, BP 215 Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE

011-33-5-56-34-06-07 Telephone:

Pascal Dupeyron Contact Person:

July 11, 1997 Date Prepared:

B. Device Identification
Common/Usual Name Proprietary Name:

Ultrasonic Surgical Aspirator DISSECTRON

C. Identification of Predicate Device(s)
The DISSECTRON is substantially equivalent to the following previously cleared and currently marketing devices:

Cooper Cavitron CUSA 200M (K864943) Sharplan 4300/4310 (K883091) Clinical Technology BOVIE (K855138A)

D. Device Description

The DISSECTRON's selective effect on tissue is the result of three combined factors:

· Ultrasonic fragmentation,
· Irrigation, and,
· Suction.

The DISSECTRON's principle of operation is tissular fragmentation which is achieved through uitrasonic longitudinal vibrations at an oscillation amplitude varying from 120 to 300um, at an operating frequency comprised between 23 and 35 kHz at the tip of the handpiece. The ultrasonic power is transmitted via a piezoelectric transducer, housed in the handpiece, which extends into a titanium sonotrode which is in direct contact with the tissue. It is possible to precisely dissect tissue with less surrounding tissue invasion and blood loss with DISSECTRON.

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Simultaneous irrigation is provided to the distal end of the tip. Sterile saline is routed from the drip holder to the control unit to the tip of the electrostrictive handpiece.

A vacuum pump aspirates emulsified tissue in the pressure range of 650 hPa. Irrigating fluid and fragmented tissue particles are continuously aspirated through the distal end of the hollow titanium sonotrode (tip) and transported, via disposable tubing, to a collection bottle ("receptacle").

The DISSECTRON, a compact, portable, tabletop ultrasonic surgical aspirator installed in the surgical suite within the user's reach, consists of three primary components:

. the base console,
the hand-piece unit, (with 2 sonotrode dedicated extensions, and, .
the control pedal (footswitch). .

The base console is controlled by a microprocessor and provides various indicators and controls designed to lead the operator through the sequential procedures needed for safe operation. Touch screen controls and displays provide the surgeon with a user friendly device.

The lightweight electrostrictive handpiece is equipped with a titanium sonotrode, which acts as an ultrasonic transmitter, and is fitted with central suction and concentric irrigation.

The foot pedal has two footswitches, a right switch, and a left switch, respectively, to control the Suction, Irrigation, and Ultrasound power.

E. Substantial Equivalence

The technical characteristics are almost identical to those of Cooper Cavitron CUSA 200 M. the Sharplan 4300/4310, and the Clinical Technology BOVIE previously cleared predicate devices. Refer to Table A for a comparison of these predicate devices. Differences that exist between these devices relating to technical specifications, materials, physical appearance, and control systems, do not affect the relative safety or effectiveness of the DISSECTRON device.

The intended use for the DISSECTRON device, as with the previously cleared devices, is for the successful fragmentation, emulsification and aspiration of soft tissue of various extirpation of any tumor in the central nervous system, inclusive of intracranial tumors, brain stem tumors, and spinal cord tumors, and neuro-acoustic tumors, and not necessarily limited to the following:

· Astrocytoma
· Cerebellopontine anglo tumors
· Cervico-facial tumors
· Metastases
· Pituitary adenoma
· Acoustic neurimoma
· Meningioma
· Glioma
· Craniopharynglomas
Deep-seated cerebral tumors

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The DISSECTRON device is not intended for use in the following applications:

any type of cardiac surgery,
· suction lipectomy,
orthopedics

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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized image of a human figure, with three profiles merging into one, representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT - 8 1997

Ms. Jacqueline E. Masse Senior Consultant Interactive Consulting, Inc. for Satelec Medical 70 Walnut Street Wellesley, Massachusetts 02181

Re : K972612 Trade Name: DISSECTRON Portable Unit Requlatory Class: Unclassified Product Code: 84LBK Dated: July 11, 1997 Received: July 14, 1997

Dear Ms. Masse:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Ms. Jacqueline E. Masse

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan Ph. D Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K972612

Device Name: DISSECTRON Portable Unit

Indications For Use:

Fragmentation, emulsification and aspiration of soft tissue in the neurosurgery field.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thomas J. Callahan

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number R972672

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

N/A