(46 days)
The Grace Medical PC Coated Tympanostomy Tubes have primary intended use as the predicate devices - A device that is intended to be implanted for ventilation or drainage of the middle ear.
Indications for Use 1)
(a) Chronic otitis media with effusion (serous, mucoid, or purulent).
(b) Recurrent episodes of acute otitis media despite conventional medical treatment.
(c) A record of persistent high negative middle ear pressure associated with one or more of the following svmptoms:
(i) Conductive hearing loss that is symptomatic.
(ii) Persistent or recurrent otalgia.
(iii) Persistent or recurrent vertigo, tinnitus, or both.
(d) Retraction pocket of the tympanic membrane.
The Grace Medical PC Coated Tympanostomy Tubes are manufactured from medical grade silicone. Each tube is coated with a layer of PC1036 phosphorylcholine. Various designs of tubes are available to meet physician preference. The PC1036 coating has been shown to be resistant to staphylococcal biofilm formation and pseudomonal biofilm formation.
The provided text is a 510(k) summary for Grace Medical PC Coated Tympanostomy Tubes. This document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It is not a clinical study report or a technical performance assessment in the way one might evaluate an AI/ML device.
Therefore, most of the requested information (acceptance criteria tables, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) is not present in this type of regulatory submission because it is not required for a 510(k) for a physical medical device like tympanostomy tubes.
A 510(k) for such a device focuses on demonstrating substantial equivalence in terms of intended use, materials, design, and performance characteristics (often bench testing, biocompatibility, sterilization, etc.) compared to existing devices. Clinical efficacy studies and detailed performance metrics, as would be expected for a diagnostic AI algorithm, are typically not part of these submissions unless there's a significant change in the device's fundamental technology or intended use that warrants new clinical evidence.
The relevant information that can be extracted or inferred from this document is:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table of acceptance criteria for a "device performance" in the sense of an algorithm's output. Instead, it describes the characteristics and intended use of the Grace Medical PC Coated Tympanostomy Tubes and compares them to predicate devices to demonstrate substantial equivalence.
| Feature / Characteristic | Grace Medical PC Coated Tympanostomy Tubes | Reported Performance / Comparison to Predicate |
|---|---|---|
| Intended Use | Ventilation & Drainage of Middle Ear | Substantially Equivalent to Predicate Devices |
| Material | Silicone w/ PC1036 Coating | Substantially Equivalent (difference in coating discussed) |
| Coating Characteristics | Resists Biofilm Formation | Shown to resist staphylococcal and pseudomonal biofilm formation (in vitro evidence cited) |
| How Shipped | Supplied Sterile | Substantially Equivalent to Predicate Devices |
| Safety & Effectiveness | Not affected by differences from predicate | FDA determined substantial equivalence |
2. Sample sized used for the test set and the data provenance: Not applicable. This is not an AI/ML device or a study involving a "test set" in that context. The "test" here refers to the overall regulatory review for substantial equivalence, not a clinical trial or algorithm validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document is about a medical device (tympanostomy tube), not a diagnostic algorithm requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
Study/Evidence that Proves the Device Meets Acceptance Criteria (Substantial Equivalence):
The "study" or evidence provided is primarily a comparison to predicate devices and reference to in vitro testing for the coating characteristic:
-
Predicate Device Comparison: The core of the 510(k) submission is to demonstrate that the Grace Medical PC Coated Tympanostomy Tubes are "substantially equivalent" to legally marketed predicate devices:
- Grace Medical, Inc. silicone tympanostomy tubes (K943325 & K981575)
- PC Coated Tympanostomy Tubes (Pacific™) (K000801) marketed by Gyrus ENT
This comparison is made across intended use, material, coating characteristics, and shipping method. The key argument is that any differences (specifically the PC1036 coating on a silicone tube) "should not affect the safety or effectiveness."
-
In Vitro Testing for Coating: To support the claim of the coating's beneficial characteristic, the document explicitly states: "The PC1036 coating has been shown to be resistant to staphylococcal biofilm formation and pseudomonal biofilm formation." It cites one reference:
- Berry JA, et.al.: In vitro resistance to bacterial biofilm formation on coated fluoroplastic tympanostomy tubes. Otolaryngology Head and Neck Surgery. 2000 Sep;123(3):246-51.
The FDA's decision letter (K062672) indicates that they reviewed the premarket notification and "determined the device is substantially equivalent... to legally marketed predicate devices." This FDA determination serves as the "proof" that the device meets the regulatory acceptance criteria for market clearance under a 510(k) pathway.
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Ko62672
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES
| Trade Name: | |
|---|---|
| Common Name: | |
| Classification Name: |
Tympanostomy Tubes Tympanostomy Tubes Tympanostomy Tubes (CFR 21 § 874.3880)
Official Contact:
Jeff Cobb
OCT 2 4 2006
Telephone: Telefax: Date Prepared: Grace Medical, Inc. 8500 Wolf Lake Drive, Suite 110 Memphis, TN 38133 (901) 380-7000 (901) 380-7001 September 8, 2006
Predicate Devices - The Grace Medical PC Coated Tympanostomy equivalent to the current silicone tympanostomy tubes marketed by Grace Medical, Inc. (K943325 & K981575) and PC Coated Tympanostomy Tubes (Pacific™) (K000801) marketed by Gyrus ENT.
Intended Use - The Grace Medical PC Coated Tympanostomy Tubes have primary intended use as the predicate devices - A device that is intended to be implanted for ventilation or drainage of the middle ear.
- Indications for Use 1)
- (a) Chronic otitis media with effusion (serous, mucoid, or purulent).
- (b) Recurrent episodes of acute otitis media despite conventional medical treatment.
- (c) A record of persistent high negative middle ear pressure associated with one or more of the following svmptoms:
- (i) Conductive hearing loss that is symptomatic.
- (ii) Persistent or recurrent otalgia.
- (iii) Persistent or recurrent vertigo, tinnitus, or both.
- (d) Retraction pocket of the tympanic membrane.
Material of Tubes - The Grace Medical PC Coated Tympanostomy Tubes are manufactured from medical grade silicone. Each tube is coated with a layer of PC1036 phosphorylcholine.
| Design Features - Various designs of tubes are available to meet physician preference. | |
|---|---|
| PC CoatedTympanostomy Tubes(Grace Medical) | UncoatedTympanostomy Tubes(Grace Medical) | PC Coated TympanostomyTubes(Gyrus ENT) | Uncoated TympanostomyTubes (Gyrus ENT) | |
|---|---|---|---|---|
| Intended Use | Ventilation &Drainage of MiddleEar | Ventilation &Drainage of MiddleEar | Ventilation & Drainage ofMiddle Ear | Ventilation & Drainageof Middle Ear |
| Material | Silicone w/ PC1036Coating | Fluoroplastic,Titanium, & Silicone | Fluoroplastic/PC1036Coating | Fluoroplastic |
| CoatingCharacteristics | Resists BiofilmFormation1 | N/A | Resists Biofilm Formation1 | N/A |
| How Shipped | Supplied Sterile | Supplied Sterile | Supplied Sterile | Supplied Sterile |
PC1036 Coating Information - The PC1036 coating has been shown to be resistant to staphylococcal biofilm formation and pseudomonal biofilm formation.
Differences between the Grace Medical PC Coated Tympanostomy Tubes and the predicate devices should not affect the safety or effectiveness.
4 Berry JA, et.al.: In vitro resistance to bacterial biofilm formation on coated fluoroplastic tympanostomy tubes. Otolaryngology Head and Neck Surgery. 2000 Sep;123(3):246-51.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Grace Medical, Inc. c/o Jeff Cobb Vice President, Regulatory Affairs & Quality 8500 Wolf Lake Drive Suite 110 Memphis, TN 38133
OCT 2 4 2006
Re: K062672
Trade/Device Name: Grace Medical PC Coated tympanostomy Tubes Regulation Number: 21 CFR 874.3880 Regulation Name: Tympanostomy tube Regulatory Class: Class II Product Code: ETD Dated: September 7, 2006 Received: September 26, 2006
Dear Mr. Cobb:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Jeff Cobb
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Eychler, M.D.
Malvina B Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: Device Name:
PC Coated Tympanostomy Tubes
-
- Indications for Use
- (a) Chronic otitis media with effusion (serous, mucoid, or purulent).
- (b) Recurrent episodes of acute otitis media despite conventional medical treatment.
- (c) A record of persistent high negative middle ear pressure associated with one or more of the following symptoms:
- (i) Conductive hearing loss that is symptomatic.
- (ii) Persistent or recurrent otalgia.
- (iii)Persistent or recurrent vertigo, tinnitus, or both.
- (d) Retraction pocket of the tympanic membrane.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | X | OR | Over-The-Counter Use(Optional Format 1-2/96) |
|---|---|---|---|
| ------------------------------------------ | --- | ---- | -------------------------------------------------- |
Seinus Norden
(Division Sign-Off) Division of Ophthalmi Nose and Throat Devi
Prescription Use
(Per 21 CFR 801.109)
X
510(k) Number K062672
Page 3
§ 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.