NMX-1000

K040584 · Neomedix Corp. · GEI · Apr 22, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K040584
• Device Name: NMX-1000
• Applicant: Neomedix Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Indications for Use

The NMX-1000™ is designed to surgically remove a strip of the Trabecular meshwork for surgical management of infantile and adult glaucoma.

Device Story

NMX-1000™ is a sterile, single-use bipolar electrosurgical probe; used for surgical management of infantile and adult glaucoma. Device features bipolar probe tip, irrigation channels, and aspiration channels; handpiece constructed of ABS plastic with stainless steel probe. Operates by connecting to a compatible electrosurgical generator; delivers low-energy radio frequency current to the probe tip to cut/remove a strip of trabecular meshwork. Used by surgeons in clinical settings; provides irrigation and aspiration capabilities similar to standard goniotomy knife cannulas. Benefits include precise tissue removal for glaucoma management.

Clinical Evidence

Bench testing only. Biological safety of patient-contact materials demonstrated per standards. Electrical safety verified via compliance with IEC 60601-1 (leakage current, dielectric voltage) and ANSI/AAMI HF-18. Device integrity, tip bend resistance, and sterility (SAL 10^-6) confirmed through bench testing.

Technological Characteristics

Bipolar electrosurgical probe; ABS plastic handpiece; stainless steel probe tip. Energy source: external compatible electrosurgical generator. Connectivity: connects to standard irrigation/aspiration devices. Sterilization: sterile, single-use. Compliance: IEC 60601-1, ANSI/AAMI HF-18.

Indications for Use

Indicated for surgical management of infantile and adult glaucoma by removing a strip of the trabecular meshwork.

Regulatory Classification

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.

Predicate Devices

• NeoMedix Microsurgical Bipolar Handpiece (K024304)

Reference Devices

• Storz Maumenee Goniotomy Knife Cannula

Submission Summary (Full Text)

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APR 2 2 2004

NeoMedix Corporation 510(k) Premarket Notification February 9, 2004

K 040584

Page 1 of 2

SECTION 2 - 510 (K) SUMMARY

# SUMMARY OF SAFETY AND EFFECTIVENESS

Date Prepared: February 9, 2004

Manufacturer and Submitter

NeoMedix Corporation 27452 Calle Arroyo San Juan Capistrano, California 92675 Phone: [phone] Fax: [phone]

Contact Person

Dr. Soheila Mirhashshemi

Common, Classification and Proprietary Names

| Common Name: | Electrosurgical electrode |
|----------------------|----------------------------------------------------------|
| Classification Name: | Radio frequency cautery device (21 CFR section 886.4100) |
| Proprietary name: | NMX-1000™ |

#### Predicate Devices

The NeoMedix NMX-1000™ is identical to the NeoMedix Microsurgical Bipolar Handpiece (K024304; GEF and The Neowedix NW/F 1000" Is ruenical to the noonthalmic surgery. The NeoMedix NMX
HQR) in general indications, materials, design and features for other Caristery knife [610K] HQR) in general indications, materials, design and leatures for opinisms con- , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

### Indications for Use

The NMX-1000™ is designed to surgically remove a strip of the Trabecular meshwork for surgical management of infantile and adult glaucoma.

#### Device Description

The NMX-1000™ is a sterile single use device that consists of a bipolar probe and channels for inigation and The NMX- IDO0™ Is a stellie Single dse device that ochalist of a special production of the device model aspiration. These chames are connected to modical group designed to operate in the bipolar model. nandplece is ABS plastic incorporates a stamess stor proble of low energy output control. The supplied when connected to a companible electrosurgical generator of the handless to standard irrigation and aspiration devices.

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NeoMedix Corporation 510(k) Premarket Notification February 9, 2004

Page 2 of ②

## Technological Characteristics Comparison

The probe is identical in design to the currently marketed NeoMedix MicroSurgical Bipolar Handpiece in that The probe is identical in design to the canciny hidriced rroand occurs at the probe tip . The irigation and the application of fadio trequency current is opplical in Rater to the Storz Maumenes aspiration capabilities are the as those of the never electrosurgical devices is well known and
Goniotomy knife cannula. The cutting capability of radio frequency an ostopli Goniotomy Knile Cannula. The Gotting Capability of Tadio Requestion materials used have an established history of safe use in similar medical devices.

#### Performance and Safety

The biological safety of the device has been demonstitility studies of all patient The bloodical salety of the device has been demonstitution the some of . Electrical safety has been a contact materials in accordance with the Standards out.infalled in IEC 60601-1 for leakage current and demonstrated by compliatic to applicable requirements as litem was performed to assure connector ANSI/AMI HF-18 Tor namplece dicience voltage. " Hyoldar costing at urinal tissues of himal tissues integrity, tip bend resistance and nature is supplied sterile and sterlier and sterlity will confirm to a Sterlily Assurance Level (SAL) of 10". The supplied instructions for use provide the user with the applicable a Sterlity Assurance Level (SAL) of 10 . The Supplied instructions of only glaucoma. Since the device warnings and caulons during use. The device is our annuisation of a that of a Gonotomy knife, there are no new safety or effectiveness issues related to this device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

APR 2 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Neomedix Corporation c/o Mr. Marc M. Mouser Underwriters Laboratories, Inc. 2600 N.W. Lake Road Camas, Washington 98607

Re: K040584

Trade/Device Name: NMX-1000TM Regulation Number: 21 CFR 878.4400, 886.4100 Regulation Name: Electrosurgical cutting and coagulation device and accessories; Radiofrequency electrosurgical cautery apparatus Regulatory Class: II Product Code: GEI, HQR Dated: April 6, 2004 Received: April 8, 2004

Dear Mr. Mouser:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encrobate) to togens and the Medical Device Amendments, or 10 commence prior to May 20, 1970, the enaoudance with the provisions of the Federal Food, Drug. devices mat have been recuire approval of a premarket approval application (PMA). and Cosmithe Ace (ree) that do noverpal controls provisions provisions of the Act. The 1 ou may, dicierore, market the Act include requirements for annual registration, listing of general controls provisions of the rice, 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 If your device to such additional controls. Existing major regulations affecting your device can thay be subject to suble additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peaces announceming your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuation of a receivice complies with other requirements of the Act that i DA has made a dolorimations administered by other Federal agencies. You must of any I cocolar surches and regarants, including, but not limited to: registration and listing (21 comply with an the 7ter 31equirements, mercess, and manufacturing practice requirements as set CITK Fart 607), labeling (21 OF R Part 820); and If applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Marc M. Mouser

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will anow you to begin finding of substantial equivalence of your device to a legally premarket notification. The PDF interessification 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 If you desire spocente acreouser - at [phone]. Also, please note the regulation entitled, Comace the Other of Compullier in (set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam 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

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NeoMedix Corporation 510(k) Premarket Notification February 9, 2004

#### INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K 040584

Device Name:

NMX-1000™

Indications for use: The NMX-1000™ is designed to surgically remove a strip of the Trabecular meshwork for surgical management of infantile and adult glaucoma.

Prescription Use: X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use: __ (Part 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)

Muriam C. Provost

(Divis Division of General, Restorative. and Neurological Devices

**510(k) Number** K040584