(208 days)
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.
Incapacitating unilateral Menière's Disease
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.
This document is a 510(k) summary for Pfleiderer's Intratympanic Catheter and does not contain the detailed study information needed to describe acceptance criteria and device performance in the way requested. It primarily focuses on demonstrating substantial equivalence to a predicate device.
However, based on the provided text, I can infer some aspects and highlight what's missing:
Missing Information:
The document lacks critical details such as:
- Specific quantitative acceptance criteria (e.g., success rates, infection rates, functional outcome scores).
- Any performance metrics beyond a general statement of "function is the same" and "fit is similar."
- Details of any formal study (clinical trial, bench test protocol, etc.) conducted to prove acceptance.
- Sample sizes for test or training sets.
- Data provenance, expert qualifications, adjudication methods, or ground truth establishment for any study.
- Information on MRMC comparative effectiveness or standalone algorithm performance.
Based on the available information, here's what can be extracted and what remains unknown regarding acceptance criteria and a "study":
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied/Inferred) | Reported Device Performance |
|---|---|
| Functional Equivalence/Ability to Deliver Medication: The device must be able to deliver therapeutic agents into the middle ear. | "The function is the same, in that they both [Pfleiderer's Intratympanic Catheter and predicate device] deliver medication." This is a qualitative statement of functional comparability, not a quantitative performance metric. |
| Fit/Retention in Middle Ear: The device must be retained in the middle ear post-insertion. | "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." This implies a retained fit, with an added benefit of perceived ease of administration, but no specific performance data. |
| Material Biocompatibility/Safety: The materials used should be appropriate for medical use. | Implicitly met by using a silicone rubber catheter, a commonly used biocompatible material in medical devices, but no specific study on biocompatibility is reported here. The 510(k) process typically requires material safety documentation, but it's not detailed in this summary. |
| Sterility: As a single-use device, it must be sterile. | Implicitly required for a single-use invasive medical device, but no specific sterility testing results or acceptance criteria are provided in this summary. |
| Mechanical Integrity/Durability: The catheter should maintain its integrity during use. | Not explicitly stated or given performance data. |
| Ease of Use/Administration: Should allow for safe and potentially easy administration. | "making it possible for the doctor or patient to perform a relatively, pain-free, self-administration of his/her medication." This is a perceived benefit, not a measured performance. |
Study Information (Based on 510(k) Submission Nature):
A 510(k) (Premarket Notification) submission like this primarily focuses on demonstrating "substantial equivalence" to a currently marketed device (predicate device). It generally relies on comparisons of device characteristics, materials, intended use, and existing performance data (often from bench testing or literature, rather than new, large-scale clinical trials) rather than new, extensive clinical studies proving efficacy and safety from scratch.
Therefore, the "study" referenced in your prompt is not explicitly detailed as a single, formal clinical trial or AI model validation study in this document. Instead, the "proof" is the comparison made against the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. This document does not describe a formal "test set" in the context of a new efficacy or performance study. The comparison is based on the device description and known characteristics of the predicate.
- Data Provenance: Not specified. Any data used to support the comparison would likely come from manufacturer's specifications, material science data for silicone, and potentially existing clinical knowledge of intratympanic catheters, but this summary doesn't detail specific data sources or geographic origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable/Not specified. This type of information is generally relevant for AI/ML validation studies or complex diagnostic device studies involving expert interpretation, which is not the nature of this 510(k) summary.
4. Adjudication Method for the Test Set
- Not applicable/Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This document does not mention an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This device is a physical medical catheter, not an algorithm.
7. The Type of Ground Truth Used
- For a 510(k) of this nature, the "ground truth" for demonstrating substantial equivalence typically involves:
- Device Specifications and Bench Testing: Comparing dimensions, materials, functional mechanisms (e.g., fluid delivery capacity, connection type) against the predicate.
- Clinical Literature/Expert Opinion: Relying on established medical understanding of materials (e.g., silicone's biocompatibility) and the function of similar catheters.
- Intended Use Alignment: Confirming the proposed indications are similar to those of the predicate device.
- No "pathology" or "outcomes data" specifically for this device are presented here as ground truth from a new study.
8. The Sample Size for the Training Set
- Not applicable/Not specified. This isn't an AI/ML device where a "training set" would be used.
9. How the Ground Truth for the Training Set was Established
- Not applicable/Not specified.
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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)
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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
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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) |
§ 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.