ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET

• K Number: K973633
• Device Name: ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET
• Manufacturer: ATRION MEDICAL PRODUCTS, INC.
• Date Cleared: 1998-01-16 ( 183 days)
• Product Code: OKS
• Regulation Number: N/A
• Type: Traditional
• Panel: Ophthalmic
• Reference & Predicate Devices: K962151
• Predicate For: N/A

Intended Use

The Atrion Medical Coated Lacrimal Intubation Set is valuable in the reconstruction of the lacrimal outflow system and also useful in canaliculus repair, lacrimal obstruction and complicated and uncomplicated dacryocystorhinostomy procedures.

Indications For Use:

1. Maintenance of lacrimal outflow post primary DCR surgical procedures.
2. Maintenance of lacrimal outflow post failed open DCR surgical procedures with complete obstruction.
3. Reconstruction of the canaliculi.

Device Description

The Atrion Medical Coated Lacrimal Intubation Set consists of two malleable stainless steel probes (to facilitate insertion) securely attached to a flexible coated silicone tube of varying thickness. The intubation set is a single-use product, sterilized by radiation.

AI/ML Overview

This document does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. Instead, it is a 510(k) premarket notification summary and a subsequent FDA substantial equivalence letter for a physical medical device: the Atrion Medical Coated Lacrimal Intubation Set.

The document discusses:

• Device Name: Atrion Medical Coated Lacrimal Intubation Set
• Intended Use: Reconstruction of the lacrimal outflow system, canaliculus repair, lacrimal obstruction, and dacryocystorhinostomy procedures.
• Technological Characteristics: The device is similar to a predicate device but has a coating on the tube for increased lubricity and easier insertion.
• Summary of Safety Testing: Biocompatibility testing (cytotoxicity, hemolysis, acute systemic toxicity, intracutaneous toxicity, implantation test, histology) was conducted to demonstrate substantial equivalence to the predicate device.
• FDA Determination: The FDA found the device substantially equivalent to a legally marketed predicate device (Ryder International Lacrimal Intubation Set, K962151) based on the safety testing and intended use.

Since this document pertains to a traditional medical device and not an AI/ML-driven device, the requested information (acceptance criteria, device performance metrics like sensitivity/specificity, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) is not applicable or present within the provided text.

Summary

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DUPLICATE

Atrion Medical Products, Inc.
1426 Curt Francis Road
Post Office Box 564
Arab, AL 35016
Tel [phone]
Fax [phone]

K973633 , and the corrected HTML is:

Atrion Medical Products, Inc.
1426 Curt Francis Road
Post Office Box 564
Arab. AL 35016	6 1998
Tel [phone]	73633
Fax [phone]
11.	SUMMARY OF SAFETY AND EFFECTIVENE
Date ofPreparation:	October 9, 1997
Device Name:	Atrion Medical Coated Lacrimal Intubation Set, K973633
Common Name:	Coated Lacrimal Intubation Set
ClassificationName:	Lacrimal Probe / Manual Ophthalmic Surgical Instrument per 21 CFR886.4350
Manufacturer:	Atrion Medical Products, Inc.1426 Curt Francis RoadArab, AL 35016
Contact:	Mr. Dan ClarkAtrion Medical Products, Inc.1426 Curt Francis RoadArab, AL 35016Telephone: [phone], Fax: [phone]
Predicate:	Ryder International Lacrimal Intubation Set, K962151
DeviceDescription:	The Atrion Medical Coated Lacrimal Intubation Set consists of twomalleable stainless steel probes (to facilitate insertion) securelyattached to a flexible coated silicone tube of varying thickness. Theintubation set is a single-use product, sterilized by radiation.
Intended Use:	The Atrion Medical Coated Lacrimal Intubation Set is valuable in thereconstruction of the lacrimal outflow system and also useful incanaliculus repair, lacrimal obstruction and complicated anduncomplicated dacryocystorhinostomy procedures.
TechnologicalCharacteristics:	The Atrion Medical Coated Lacrimal Intubation Set will be identical tothe predicate except that it will have a coating on the tube toIncrease lubricity and facilitate insertion.
Summary ofSafety Testing:	Based on biocompatibility testing, including cytotoxicity, hemolysis (invitro), acute systemic toxicity, intracutaneous toxicity, implantationtest and histology of the implant site, we conclude that the newdevice is substantially equivalent to the predicate device under theFederal Food, Drug and Cosmetic Act.
	000028

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The logo is simple and clean, and it is easily recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 112008

Mr. Dan Clark Vice President Atrion Medical Products, Inc. 1426 Curt Francis Road P.O. Box 564 Arab, AL 35016

Re: K973633

Trade/Device Name: Atrion Medical Products Lacrimal Intubation Set Regulatory Class: Unclassified Product Code: OKS Dated: January 8, 1998 Received: January 12, 1998

Dear Mr. Clark:

This letter corrects our substantially equivalent letter of January 16, 1998.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Malvina B. Epler, und

Malvina B. Eydelman, M 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 (if known): K973633

Device Name: Atrion Medical Coated Lacrimal Intubation Set

Indications For Use:

• Maintenance of lacrimal outflow post primary DCR surgical procedures. 1.
• Maintenance of lacrimal outflow post failed open DCR surgical procedures with complete 2. obstruction.
• Reconstruction of the canaliculi. 3.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF. . . . . . . . . . . . . . . NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)
Over-The- Counter Use

Division Sign-Off
Division of Ophthalmic Devices
510(k) Number	K973633

(Optional Format 1-2-96)	000030
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Regulation Number and Section

N/A