(173 days)
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.
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.
The provided text describes a medical device called the "RW E-Cath™" and its performance testing, but it does not contain the specific information requested in the prompt regarding acceptance criteria, a study proving device meets acceptance criteria, detailed sample sizes, expert involvement, or comparative effectiveness studies.
The document is a 510(k) Summary submission to the FDA, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results or acceptance criteria against specific performance targets.
Here's a breakdown of what is available and what is missing:
1. A table of acceptance criteria and the reported device performance:
- Missing. The document states: "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." However, it does not provide the specific acceptance criteria (e.g., "pressure vs. flow must be X to Y") nor the reported performance values from these tests. It only mentions that "All tests will be conducted on final sterile product" and "Sufficient samples will be used for each test."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Missing. The document states, "Sufficient samples will be used for each test." No specific sample sizes, data provenance, or study design (retrospective/prospective) are mentioned. The testing described is "bench testing," not clinical data.
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):
- Not applicable. The described testing is bench testing of physical properties (pressure vs. flow, bond strength, tensile strength, electrode integrity). This type of testing does not involve establishing ground truth from experts in the way an imaging or diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As above, bench testing of physical properties does not typically involve expert adjudication for a "test set" in the context of clinical or diagnostic performance.
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:
- No. This device is a medical catheter with an electrode, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is hardware (a catheter with an electrode) used for irrigation and electrophysiological potential recording. It does not operate as a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable / Missing. For the bench tests ("pressure vs. flow, distal tip bond strength, tensile strength of the catheter body, proximal hub bond strength, and clectrode integrity"), the "ground truth" would be the objective measurements obtained from standardized testing methods against pre-defined engineering specifications. These specifications and the results are not provided.
8. The sample size for the training set:
- Not applicable. There is no mention of a "training set" as this is a hardware device undergoing bench testing, not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set or machine learning model is discussed.
In summary, the provided document focuses on the description, intended use, principles of operation, technological characteristics, and a high-level overview of bench performance testing for a medical device submitted for 510(k) clearance. It lacks the detailed information about acceptance criteria, specific test results, sample sizes, expert involvement, and study designs typical of performance claims for diagnostic or AI-driven devices.
{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)
§ 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.