(48 days)
Not Found
No
The summary describes a surgical device with electrosurgical and irrigation/aspiration capabilities, with no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is designed to surgically remove a strip of the Trabecular meshwork for the surgical management of glaucoma, which is a therapeutic intervention.
No
The device is designed for the surgical removal of tissue, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components such as a bipolar probe, channels for irrigation and aspiration, medical tubing, an ABS plastic handpiece, and a stainless steel probe. It also mentions being connected to a compatible electrosurgical generator and standard irrigation and aspiration devices, all of which are hardware.
Based on the provided information, the NMX-1000™ is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to surgically remove a strip of the Trabecular meshwork for surgical management of infantile and adult glaucoma." This is a surgical procedure performed directly on a patient's tissue in vivo (within the living body).
- Device Description: The device is described as a "sterile single use device that consists of a bipolar probe and channels for irrigation and aspiration." This is a surgical instrument designed for physical manipulation of tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. The NMX-1000™ does not perform any such analysis of specimens.
The NMX-1000™ is a surgical device used for a therapeutic procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI, HQR
Device Description
The NMX-1000™ is a sterile single use device that consists of a bipolar probe and channels for inigation and aspiration. These channales are connected to medical group designed to operate in the bipolar model. The handplece is ABS plastic incorporates a stainless steel problematic low energy output control. The supplied when connected to a companible electrosurgical generator of the handless to standard irrigation and aspiration devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Trabecular meshwork (for surgical management of infantile and adult glaucoma)
Indicated Patient Age Range
infantile and adult
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)
The biological safety of the device has been demonstrated by biocompatibility studies of all patient contact materials in accordance with the Standards outlined in ISO 10993. Electrical safety has been demonstrated by compliance to applicable requirements as detailed in IEC 60601-1 for leakage current and ANSI/AAMI HF-18 for handpiece disistence voltage. A bipolar coating integrity, tip bend resistance and flexural strength an evaluation of prototype, was performed to assure connector integrity, and function of the device. The device is supplied sterile and sterility will confirm to a Sterility Assurance Level (SAL) of 10⁻⁶. The supplied instructions for use provide the user with the applicable warnings and cautions during use. Since the device is an application of radiofrequency energy that replaces an existing mechanical action that of a Gonoitomy knife, there are no new safety or effectiveness issues related to this device.
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.
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
§ 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.
0
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: (949) 248-7029 Fax: (949) 248-7119
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.
1
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.
2
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.
3
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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
4
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