(208 days)
Not found
Not Found
No
The summary describes a simple mechanical catheter for drug delivery and explicitly states that AI, DNN, or ML are not mentioned.
Yes
The device is used for the "repeated, safe delivery of therapeutic agents into the middle ear, to facilitate the control of disabling vertigo arising from active unilateral Meniere's Disease." The delivery of therapeutic agents implies a therapeutic purpose.
No
The device is described as a "closed system for the repeated, safe delivery of therapeutic agents," which indicates a therapeutic rather than a diagnostic function. It is used to deliver agents to control vertigo, not to diagnose a condition.
No
The device description explicitly states it consists of a silicone rubber catheter and other physical components, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. They are used to diagnose diseases, conditions, or states of health. Examples include blood tests, urine tests, and tissue biopsies.
- This device is used to deliver therapeutic agents directly into the middle ear. It is a delivery system for treatment, not a tool for analyzing biological samples to gain diagnostic information.
The intended use clearly describes a therapeutic intervention (delivery of agents to control vertigo), not a diagnostic process.
N/A
Intended Use / Indications for Use
For use as a closed system for the repeated, safe delivery of therapeutic agents into the middle ear, to facilitate the control of disabling vertigo arising from active unilateral Meniere's Disease.
Product codes
77 ETD
Device Description
This single use device consists of a silicone rubber catheter, 21cm in length, with a spring loaded Luer lock at one end and a soft rubber flange, to retain the device in the middle ear, at the other.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
middle ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
doctor or patient / 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)
Portex Remote Injection Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/0 description: The image shows the logo for Exmoor Plastics. On the left side of the logo is a drawing of a deer head with large antlers. To the right of the deer head is the company name, with "Exmoor" on top of "Plastics."
Our Ref:
1974008
Image /page/0/Picture/3 description: The image contains two logos. The logo on the left is a circular logo with the text "QUALITY ASSURED FIRM ISO 9001" surrounding the letters "SGS" with a checkmark below. The logo on the right has a crown on top of a checkmark with the text "NATIONAL ACCREDITATION OF CERTIFICATION BODIES" below.
MAY | 3 1998
Your Ref:
| Contact: Margaret Blackmore | |
|---|---|
| 14 April 1998 | |
| SUMMARY OF SAFETY & EFFECTIVENESS | |
| Trade Name: | Pfleiderer's Intratympanic Catheter |
| Common Name: | Intratympanic Catheter |
| Classification Name: | Catheter Eustachian, General and Plastic Surgery |
| Predicate Devices: | Portex Remote Injection Catheter |
| Description of Device: | This single use device consists of a silicone rubber catheter, 21cm in length, with a spring loaded Luer lock at one end and a soft rubber flange, to retain the device in the middle ear, at the other. |
| Intended Use: | For use as a closed system for the repeated, safe delivery of therapeutic agents into the middle ear, to facilitate the control of disabling vertigo arising from active unilateral Meniere's Disease. |
| Comparison with Predicate Devices: | The Portex Remote Injection Catheter is constructed of nylon tubing, with a Luer connector at one end and a Luer lock mount at the other similar. |
The Exmoor Intratympanic Catheter is constructed of silicone tubing with a silicone bevelled flange at one end and a one-way Luer valve at the other.
The function is the same, in that they both deliver medication. The fit is similar, except that a silicone flange replaces the lock mount, making it possible for the doctor or patient to perform a relatively, pain-free, self-administration of his/her medication. |
MB/PAS/K974008
Exmoor Plastics Ltd., Lisieux Way, Taunton, TA1 2LB, U.K.
Co. Reg. No:
2075762 (Eng)
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The eagle is depicted in a simple, black-and-white design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 1998
Margaret Blackmore Regulatory Affairs Exmoor Plastics, Ltd. Lisieux Way Taunton, TA1 2LB U.K. Re:
K974008 Pfleiderer's Intratympanic Catheter Dated: April 14, 1998 Received: April 17, 1998 Regulatory class: II 21 CFR 874.3880/Procode: 77 ETD
Dear Ms. Blackmore:
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 Fecteral 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 531 through 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/cdrl/dsmaldsmamain.html".
Sincerely yours,
Kilian Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
RAM/19/A/1
(1) B =
Device Listing Number: A875609
510(k) Number (if known):___974008
Device Name: Pfleiderer's Intratympanic Catheter
Indications for Use:
Incapacitating unilateral Menière's Disease
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off)Division of Reproductive, Abdominal, ENT,and Radiological Devices | (Division Sign-Off) | Division of Reproductive, Abdominal, ENT, | and Radiological Devices | ||
|---|---|---|---|---|---|
| (Division Sign-Off) | |||||
| Division of Reproductive, Abdominal, ENT, | |||||
| and Radiological Devices | |||||
| 510(k) Number | K974008 |
| Prescription Use | ✓ | OR | Over-The-Counter Use _ |
|---|---|---|---|
| (Per 21 CFR 801.109) |