(30 days)
No
The summary describes a simple accessory line pack for surgical systems, with no mention of AI, ML, image processing, or data analysis capabilities.
No.
The device is an accessory used for air and fluid exchange during ophthalmic surgical procedures, not a therapeutic device itself.
No
The device is an accessory for microsurgical systems used for air and fluid exchange during ophthalmic procedures, not for diagnosis.
No
The device description clearly states it is a "Line Pack" and provides a "pathway" for air, indicating it is a physical accessory and not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "air and fluid exchange during posterior segment ophthalmic procedures." This describes a surgical accessory used during a procedure on a patient, not a test performed in vitro (outside the body) on a sample to diagnose a condition.
- Device Description: The description reinforces its role as an "air exchange system during posterior segment ophthalmic surgical procedures," routing air into the eye. This is a functional component of a surgical system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on laboratory testing.
Therefore, the Bausch & Lomb™ D4600A Air Exchange Line Pack is a surgical accessory, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bausch & Lomb D4600A Air Exchange Line Pack is intended to be used as an accessory to the Bausch & Lomb Stellaris (K063331) Microsugrical System. The device is for use as an air exchange system during posterior segment ophthalmic surgical procedures. The D4600A Air Exchange Line provides the initial pathway through which air generated by the microsurgical system is routed into the posterior chamber of the eye.
The Bausch & Lomb™ D4600A Air Exchange Line Pack is intended to be used as an accessory to the Bausch & Lomb STELLARIS® and Bausch & Lomb MILLENNIUM®, Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic procedures.
Product codes
HQC
Device Description
The Bausch & Lomb D4600A Air Exchange Line Pack is intended to be used as an accessory to the Bausch & Lomb Stellaris (K063331) Microsugrical System. The device is for use as an air exchange system during posterior segment ophthalmic surgical procedures. The D4600A Air Exchange Line provides the initial pathway through which air generated by the microsurgical system is routed into the posterior chamber of the eye.
The Bausch & Lomb D4600A Air Exchange Line Pack is designed to deliver air to the eye during posterior surgical procedures. It is recommended for use with Bausch & Lomb STELLARIS® or MILLENNIUM® Microsurgical Systems. It includes instructions for use, is for single patient use, and is provided sterile via Gamma Irradiation (Cobalt). Packaging is singly in Tyvek® and PET/PE Pouch, with 6 pouches per box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior chamber of the eye, eye
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for Bausch & Lomb. The logo consists of the company name, "Bausch & Lomb", in a serif font. Above the name is a geometric design, possibly representing a lens or other optical element, rendered in a halftone pattern.
AUG 2 8 2008
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following information is provided in accordance with requirements of 21CFR 807.92:
| Contact Person: | Ned Luce
Director Regulatory Affairs
Global Surgical Devices |
|----------------------|--------------------------------------------------------------------------------|
| Date Prepared: | July 24, 2008 |
| Proprietary Name: | Bausch & Lomb D4600A Air Exchange Line Pack |
| Common/Usual Name: | Ophthalmic surgical system accessory pack for
posterior segment procedures. |
| Classification Name: | System, Phacofragmentation (86 HQC) |
Device Description/Intended Use
The Bausch & Lomb D4600A Air Exchange Line Pack is intended to be used as an accessory to the Bausch & Lomb Stellaris (K063331) Microsugrical System. The device is for use as an air exchange system during posterior segment ophthalmic surgical procedures. The D4600A Air Exchange Line provides the initial pathway through which air generated by the microsurgical system is routed into the posterior chamber of the eye.
Predicate Device: The proposed Bausch & Lomb D4600A Air Exchange Line Pack is substantially equivalent to the existing Bausch & Lomb D4600 Air Exchange Line Pack (K962131) for use with the Bausch & Lomb MILLENNIUM® Microsurgical System (K961310). The subject device may be used with each of these systems.
Predicate Comparison: A chart comparing the Bausch & Lomb D4600A to the predicate Bausch & Lomb D4600 device demonstrates substantial equivalence is attached.
1
DEVICE COMPARISON CHART Bausch & Lomb D4600A Air Exchange Line Pack
| DEVICE | Bausch & Lomb
D4600A
Subject Device | Storz D4600
K962131 |
|----------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Intended Use | To deliver air to the
eye during posterior
surgical procedures | To deliver air to the
eye during posterior
ophthalmic surgical
procedures |
| Recommended System | Bausch & Lomb
STELLARIS® or
MILLENNIUM®
Microsurgical Systems | Bausch & Lomb
PREMIERE®
Microsurgical System |
| Instructions for Use
Included | Yes | Yes |
| Single Patient Use? | Yes | Yes |
| Provided Sterile? | Yes | Yes |
| Sterilization Method | Gamma Irradiation
(Cobalt) | Gamma Irradiation |
| Packaging | Singly in Tyvek® and
PET/PE Pouch
6 pouches per Box | Singly in Tyvek® and
PET/PE Pouch
10 pouches per Box |
.
2
Image /page/2/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bausch & Lomb, Inc. c/o Ned Luce Director Regulatory Affairs Global Surgical Devices 1400 North Goodman Street Rochester, NY 14609
AUG 2 8 2008
Re: K082132
Trade/Device Name: Bausch & Lomb™ D4600A Air Exchange Line Pack Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: II Product Code: HQC Dated: July 24, 2008 Received: July 29, 2008
Dear Mr. Luce:
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.
3
Page 2 - Ned Luce
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. Egleston, und
Malvina B, Eydelman, M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
082132
Indications for Use
510(k) Number (if known):
Device Name:
Bausch & Lomb D4600A Air Exchange Line Pack
Indications for Use:
The Bausch & Lomb™ D4600A Air Exchange Line Pack is intended to be used as an accessory to the Bausch & Lomb STELLARIS® and Bausch & Lomb MILLENNIUM®, Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic procedures.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use ( 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bruce Drum
vision of Ophthalmic Ear Nose and Throat De
510(k) Number K082132