K Number

Device Name

DYONICS POWER CONTROL UNIT

Manufacturer

SMITH & NEPHEW, INC.

Date Cleared

2003-02-20

(30 days)

Product Code

HRX

Regulation Number

888.1100

Intended Use

The Dyonics® Power-HERMES READY™ control unit is indicated for use, when used with appropriate procedure specific blades, for resection of soft and osseous tissues including, but not limited to, use in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure.

Device Description

The Dyonics® Power-HERMES READY™ control unit is is an electro-mechanical device containing systems, controls, and indicators which provides electrical power to motorized hand pieces and accessories for resection of soft and osseous tissue in arthroplasty, synovectorny and intraarticular cutting and shaving. The control unit allows a surgeon to set the blade speed within minimum and maximum speeds programmed for each blade type. The Dyonics® Power-HERMES READY™ control unit incorporates a communication interface for voice activation with the HERMES™ control center. When connected to the HERMES™ control center, the control unit may be voice activated or activated manual by use of a hand held pendant.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes an electro-mechanical device for tissue resection with voice activation capabilities, but there is no mention of AI or ML in the device description, intended use, or any other section.

Therapeutic

Yes
The device is indicated for resection of soft and osseous tissues in various anatomical sites, which is a therapeutic purpose.

Diagnostic

No
The device is described as an electro-mechanical device for resection of soft and osseous tissues, not for diagnosis. Its intended use is to power instruments for surgical procedures.

SaMD (Software as a Medical Device)

The device description explicitly states it is an "electro-mechanical device containing systems, controls, and indicators which provides electrical power to motorized hand pieces and accessories." This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Dyonics® Power-HERMES READY™ control unit is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. The intended use and device description clearly state that this device is used for the resection (cutting and removal) of soft and osseous tissues within the body during surgical procedures.
The device description focuses on electro-mechanical function and providing power to surgical tools. It does not mention any analysis of biological samples.
The anatomical sites listed are internal body cavities.

Therefore, the Dyonics® Power-HERMES READY™ control unit is a surgical device used for tissue manipulation during procedures, not an IVD device used for laboratory testing of samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

HRX

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

large articular cavities, small articular cavities

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

K030196

150 Minuteman Road, Andover, MA 01810-1031 U.S.A.

FEB 2 0 2003

Exhibit H

Smith = Nephew

Endoscopy Division

Smith & Nephew, Inc.

Telephone: 978-749-1000 Fax: 978-749-1599

510(k) Summary Dyonics® Power-HERMES READYTM Date Prepared: January 20, 2003

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92

A. Submitter

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810

B. Company Contact

Janice Haselton Regulatory Affairs Specialist II

C. Device Name

Trade Name: Dyonics® Power-HERMES READYTM Common Name: Power control unit Classification Name: Ear, Nose, and throat electric or pneumatic surgical drill and Arthroscopes and Accessories

D. Predicate Devices

The Smith & Nephew Dyonics® Power-HERMES READY™ Control Unit is substantially equivalent in design, materials, function and intended use to the following devices in commercial distribution: Dyonics ® Power Control Unit

E. Description of Device

F. Intended Use

The Dyonics® Power -HERMES READY™ control unit is indicated for use, when used with appropriate procedure specific blades, for resection of soft and osseous tissues including, but not limited to, use in large articular cavities, small articular cavities, and Functional Endoscopic Sinus Surgery (FESS). The FESS application is limited to those small blades which are appropriate for the procedure.

G. Comparison of Technological Characteristics

Dyonics®Power/Hermes Page 146 of 147

The Dyonics Power®-HERMES READY™ has the same technological characteristics and intended use as the predicate device, Dyonics Power®. The addition of a communication interface for voice activation with the HERMES™ control center offers the surgeon direct communication with the device without changing the intended use or features of the Dyonics Power control unit.

The Dyonics Power®-HERMES READY™ will be tested with the following domestic and international standards:

UL 2601-1: Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety ●
IEC 60601-1: Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety + . Amendments 1 and 2
IEC 60601-1-1 : Medical Electrical Equipment General Requirements for Safety 1, Collateral Standard: Safety ● Requirements for Medical Electrical Systems
IEC 60601-1-2: Medical Electrical Equipment General Requirements for Safety2, Collateral Standard: ● Electromagnetic Compatibility- Requirements and Tests
CAN/CSA C22.2 No. 601.1-M90- Medical Electrical Equipment General Requirements for Safety: A ● National Standard for Canada

Janice Hazelton
Regulatory Affairs Specialist

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2003

Ms. Janice Haselton Regulatory Affairs Specialist Smith & Nephew, Inc. Endoscopy Division 150 Minuteman Road Andover. Massachusetts 01810-1031

Re: K030196

Trade Name: Dyonics Power Control Unit Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: January 20, 2003 Received: January 21, 2003

Dear Ms. Haselton:

We have reviewed your Section 510(k) premarket 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) 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.

Page 2 - Ms. Janice Haselton

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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Muriam C. Provost

( Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Exhibit B

Indications for Use Statement

510(k) Number (if known)

K030196

Device Name

Dyonics® Power-HERMES READYTM

Indications for Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Miriam C. Provost

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

510(k) Number K630/96

Dyonics®Power/Hermo Page 48 of 147