(166 days)
An implant to bypass the obstructed lacrimal drainage system for the treatment of chronic epiphora.
The device of this submission is identical to the predicate devices except that the MEDPOR® Porous Polyethylene is formed around the glass tube.
This 510(k) premarket notification for the MEDPOR® Coated Tear Drain (K012108) explicitly states that the device is substantially equivalent to predicate devices. This means that instead of presenting new performance data against specific acceptance criteria, the manufacturer is asserting that the new device is as safe and effective as existing legally marketed devices.
Therefore, the provided document does not contain a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for a novel device.
For K012108, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate devices. The "study" proving this primarily involves a comparison of the new device's design, materials, and indications for use to those of the predicate devices.
Given this context, I will address the requested information based on what is available and explain why certain information is not present in a 510(k) submission focused on substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as per 510(k) submission) |
|---|---|
| Design and Materials: Identical or very similar to predicate devices. | The device of this submission is identical to the predicate devices except that the MEDPOR® Porous Polyethylene is formed around the glass tube. This indicates a minor design modification around existing predicate components. |
| Intended Use/Indications: Same as predicate devices. | Indications for Use: "An implant to bypass the obstructed lacrimal drainage system for the treatment of chronic epiphora." This matches the intended use for similar lacrimal drain implants. |
| Functionality: Expected to perform comparably to predicate devices in bypassing an obstructed lacrimal drainage system. | Not explicitly stated as a quantified performance metric. Substantial equivalence relies on the assumption that the minor design change (coating the existing glass tube) does not negatively impact functionality compared to the predicate, and in fact, the coating is likely intended to improve integration. |
| Safety and Biocompatibility: Materials are well-established for use in medical implants (MEDPOR® Porous Polyethylene, borosilicate glass). | MEDPOR® Porous Polyethylene is a predicate device material (MEDPOR® Surgical Implant Material). Borosilicate glass Jones tube is also a predicate. This implies that the materials' safety and biocompatibility are already established. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of a substantial equivalence claim based on design and material comparison. No separate "test set" of patient data or clinical outcomes is presented in this 510(k) summary for performance evaluation.
- Data Provenance: Not applicable. The "proof" is the comparison against the legally marketed predicate devices, not new clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth for a test set is not established in this type of submission.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No test set requiring expert adjudication is presented.
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
- MRMC Study: No. This device is a physical implant, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable for new device performance in this submission. The "ground truth" for substantial equivalence is the established safety and effectiveness of the legally marketed predicate devices.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. This is not an AI/machine learning device.
Summary of the "Study" (Demonstration of Substantial Equivalence):
The "study" for this 510(k) submission is a comparison to predicate devices. The manufacturer demonstrates that the MEDPOR® Coated Tear Drain is substantially equivalent to:
- MEDPOR® Surgical Implant Material: This predicate provides the basis for the porous polyethylene material used.
- Pre-amendment borosilicate glass Jones tube: This predicate provides the basis for the glass tube component.
The key argument for substantial equivalence is that the new device's design is "identical to the predicate devices except that the MEDPOR® Porous Polyethylene is formed around the glass tube." This minor modification is presented as not raising new questions of safety or effectiveness and maintaining the same indications for use as the predicates. The FDA's decision to grant substantial equivalence implies agreement with this assessment.
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Kolz108
DEC 1 9 2001
Image /page/0/Picture/2 description: The image shows the logo for POREX SURGICAL PRODUCTS GROUP. The word "POREX" is in large, bold, sans-serif font, with a stylized "O" that has a circular arrow design within it. Below the word "POREX" is the text "SURGICAL PRODUCTS GROUP" in a smaller, sans-serif font.
510(k) SUMMARY
Manufacturer and Submitter
Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265
Tel: (678) 479-1610 Fax: (678) 423-1437
Contact: Howard Mercer, Ph.D. e-mail: howard_mercer@porex.com
Date: November 5, 2001
Trade Name: MEDPOR® Coated Tear Drain Class II Device 510(k) Number K012108
Substantially equivalent to:
- MEDPOR® Surgical Implant Material A.
- Pre-amendment borosilicate glass Jones tube B.
Device description:
The device of this submission is identical to the predicate devices except that the MEDPOR® Porous Polyethylene is formed around the glass tube.
Indications for Use:
An implant to bypass the obstructed lacrimal drainage system for the treatment of chronic epiphora.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 16 2008
Attn: Howard Mercer, Ph.D. Regulatory Affairs Manager Porex Surgical, Inc. 150 Dart Road Newman, GA 30265
Re: K012108 Trade/Device Name: Medpor coated tear drain Regulatory Class: Unclassified Product Code: OKS (Lacrimal System Repair Device) Dated: November 5, 2001 Received: November 7, 2001
Dear Dr. Mercer:
This letter corrects our substantially equivalent letter of December 19, 2001.
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 (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 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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Malvina B. Epple, und
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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INDICATION FOR USE
Applicant: Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265
Tel: (678) 479-1610 Fax: (678) 423-1437
510(k) Number: K012108
Device Name: MEDPOR® Coated Tear Drain
Indications for Use:
An implant to bypass the obstructed lacrimal drainage system for the treatment of chronic epiphora.
(PLEASE DO NOT WRITE BELOW THIS LINE)
$\Signature$
Division of Ophthal Nose and Throat De
510(k) Number
Prescription Use: (Per 21CFR801.109 OR
Over the Counter Use:
N/A