(166 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on material composition and form, not computational capabilities.
Yes
The device is described as an "implant to bypass the obstructed lacrimal drainage system for the treatment of chronic epiphora," indicating it provides a direct medical treatment for a condition.
No
Explanation: The device is an implant designed to bypass an obstructed lacrimal drainage system. Its intended use is treatment (therapeutic), not diagnosis.
No
The device description clearly states it is an "implant" and describes physical components like "MEDPOR® Porous Polyethylene" and a "glass tube," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is an "implant to bypass the obstructed lacrimal drainage system for the treatment of chronic epiphora." This describes a surgical device used in vivo (within the body) to treat a physical condition.
- Device Description: The device is described as an "implant" formed around a glass tube. This further reinforces its nature as a physical device intended for implantation.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, this device falls under the category of a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
An implant to bypass the obstructed lacrimal drainage system for the treatment of chronic epiphora.
Product codes
OKS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lacrimal drainage system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
MEDPOR® Surgical Implant Material A, Pre-amendment borosilicate glass Jones tube B
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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.
1
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.
2
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
3
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: