(173 days)
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Not Found
No
The device description and performance studies focus on the mechanical and electrical properties of the catheter and electrode, with no mention of AI or ML for data analysis or device function.
No
The device is indicated for irrigation and recording of inner ear potentials, which are diagnostic/procedural functions, not therapeutic.
Yes
The device is indicated for "recording of evoked electrophysiological inner ear potentials", which is a diagnostic function.
No
The device description clearly outlines physical components including a triple-lumen tube, fenestrated reservoir tip, electrode wire lead, and lead connector. It also describes bench testing of physical properties like pressure vs. flow and bond strength, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "irrigation of the middle ear including the round window area of the middle ear and/or the recording of evoked electrophysiological inner ear potentials." This involves a procedure performed directly on the patient's body (in vivo) and the recording of electrical signals from the inner ear.
- Device Description: The device is a catheter with an electrode intended to be placed in the middle ear. It facilitates irrigation and records electrical potentials.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. This device does not process or analyze biological specimens in this manner.
The device is clearly intended for a diagnostic procedure performed in vivo (within the living body) to assess the function of the inner ear through electrophysiological recordings. This falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RW E-Cath™ is indicated for irrigation of the middle ear including the round window area of the middle ear and/or the recording of evoked electrophysiological inner ear potentials.
Product codes (comma separated list FDA assigned to the subject device)
77 ETD, 84 GXY
Device Description
The RW E-Cath™ is an accessory to a tympanostomy tube. The RW E-Cath™ consists of a single triple-lumen tube opening into a hollow fenestrated reservoir tip on the distal end. Two lumcns are empty and are intended to allow fluid inflow and outflow. The third lumen encases the electrode wire lead and insulates it from the other two lumens. The atraumatic blunt distal tip of the electrode is the only part of the electrode that is exposed. The exposed distal tip of the electrode is located on the outside edge of the distal tip where it is intended to come into contact with the floor of the bony round window niche. The proximal end of the electrode contains a lead connector which the treating physician or audiologist can attach to a standard evoked potential recording instrument.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
middle ear, round window area of the middle ear, inner ear, cochlea, auditory nerve
Indicated Patient Age Range
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Intended User / Care Setting
treating physician or audiologist
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A bench test protocol was developed to assess the performance of the RW E-Cath™ in terms of pressure vs. flow, distal tip bond strength, tensile strength of the catheter body, proximal hub bond strength, and clectrode integrity. All tests will be conducted on final sterile product. Sufficient samples will be used for each test. Each sample will also be visually inspected for workmanship and dimensional compliance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 874.3880 Tympanostomy tube.
(a)
Identification. A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.(b)
Classification. Class II.
0
Neuro-Biometrix, Inc.
7995 East Prentice Ave., Suite 110; Greenwood Village, CO 80111 (303) 850-0670 Fax (303) 850-0671
Image /page/0/Picture/2 description: The image shows a black and white abstract design. The design features a series of overlapping loops or curves, creating a sense of movement and complexity. The thick lines and stark contrast contribute to a bold and graphic aesthetic.
MAR 2 3 1998
K 973740
8
Appendix 9
510(K) Summary.
| Contact Person: | |
|---|---|
| Date Summary Prepared: | |
| Trade Name: | |
| Common Name: | |
| Classification Name: |
Michael H. Arenberg September 29, 1997 Round Window E-Cath™ (RW E-Cath™) Middle Ear Catheter with Electrocochleography Electrode Class II
Equivalence: The RW E-Cath™ is substantially equivalent to the combination of the following legally marketed predicate devices; (1) the Round Window µ Cath™; (2) the Ear Electrode; and (3) the Transtympanic Needle Electrode. The RW E-Cath™ and the combination of the predicates have the same indications for use, and pose substantially similar risks..
The RW E-Cath™ is an accessory to a tympanostomy tube. The RW E-Description: Cath™ consists of a single triple-lumen tube opening into a hollow fenestrated reservoir tip on the distal end. Two lumcns are empty and are intended to allow fluid inflow and outflow. The third lumen encases the electrode wire lead and insulates it from the other two lumens. The atraumatic blunt distal tip of the electrode is the only part of the electrode that is exposed. The exposed distal tip of the electrode is located on the outside edge of the distal tip where it is intended to come into contact with the floor of the bony round window niche. The proximal end of the electrode contains a lead connector which the treating physician or audiologist can attach to a standard evoked potential recording instrument.
Intended use: The RW E-Cath™ is indicated for irrigation of the middle ear including the round window area of the middle ear and/or the recording of evoked electrophysiological inner ear potentials.
Principles of Operation: The inflow lumen is designed to allow fluid to be delivered from the proximal end of the device to the distal reservoir tip, where it can exit the device via fenestrations in the soft, flexible reservoir tip. The outflow lumen is intended to (1) relieve or avoid a build up of air and/or fluid pressure in the device; and (2) facilitate the removal of fluid from the device. The inflow-outflow design is intended to allow the treating physician to, without removing the device, add additional fluid, remove fluid or flush the system completely and refill it with new fluid. The third lumen contains the electrode leaving the blunt end exposed at the distal tip of the device where it can pick up stimulus dependent electrophysiological potentials from the cochlea and auditory nerve.
Technological Characteristics: The RW E-Cath™ and the prodicate devices, the Round Window u Cath™, the Ear Electrode, and the Transtympanic Needle Electrode are constructed of
Inner Ear Innovations for the 21st Century
1
class VI biocompatible materials (even though the electrode materials are different). Each has been subjected to biocompatibility testing.
Performance Testing: A bench test protocol was developed to assess the performance of the RW E-Cath™ in terms of pressure vs. flow, distal tip bond strength, tensile strength of the catheter body, proximal hub bond strength, and clectrode integrity. All tests will be conducted on final sterile product. Sufficient samples will be used for each test. Each sample will also be visually inspected for workmanship and dimensional compliance. 1
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 1998
Michael H. Arenberg Vice President Neuro-Biometrix, Inc. 7995 East Prentice Ave. Suite 110 Greenwood Village, CO 80111
Re:
K973740 Round Window E-Cath™ January 15, 1998 Dated: Received: January 16, 1998 Regulatory class: II 21 CFR 874.3880/Procode: 77 ETD 21 CFR 882.1320/Procode: 84 GXY
Dear Mr. Arenberg:
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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4613. 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 regulation 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 (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
William Yin
Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
7 3740
3) Statement of Indications For Use
The Round Window E-Cath™ is indicated for irrigation of the middle ear including the round window area of the middle ear and/or the recording of evoked electrophysiological inner ear potentials.
David A. Seysom
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)