(21 days)
Not Found
Not Found
No
The description focuses on the mechanical function and design of a phacoemulsification needle, with no mention of AI or ML capabilities.
No
The device is strictly used for the emulsification of an opacified crystalline lens, which is a surgical procedure and not a therapeutic one. Therapeutic devices are typically used for treatment or prevention of a disease or condition.
No
Explanation: The device, Phaco Needles, is described as contacting and fragmenting a cataractous crystalline lens to emulsify it. This is a therapeutic action, not a diagnostic one.
No
The device description clearly states it is a "cylindrical, metal tip" and a "component of a phaco system," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "emulsification of an opacified crystalline lens" during cataract surgery. This is a surgical procedure performed directly on the patient's eye.
- Device Description: The description details a surgical tool (a needle) used to physically break down the lens within the eye.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. This device does not perform any such analysis of specimens.
The device is a surgical instrument used in vivo (within the living body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The Phaco Needles are intended for use with a Bausch & Lomb Millennium, Protegé or Premiere Microsurgical System for the emulsification of an opacified crystalline lens.
Product codes (comma separated list FDA assigned to the subject device)
HQC
Device Description
The phacoemulsification (phaco) needle is the cylindrical, metal tip which is connected to the distal end of a phaco handpiece. The needle is the component of a phaco system which, as driven by the ultrasonic handpiece, contacts and fragments the cataractous crystalline lens. Irrigation fliud flows around the external surface of the needle into the eye. The emulsified lens material and irrigant are aspirated from the eye through the phaco needle lumen. The proposed Phaco Chop Needle has the same external and internal tip design as Bausch & Lomb's currently marketed MicroFlow and MicroFlow Plus Needles. However, the internal restriction is deeper within the needle bore
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
opacified crystalline lens (ocular)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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
(041998
AUG 1 6 2004
Phaco Chop Needle
510(k) SUMMARY (per 21 CFR §807.92)
| Submitter's Name: | Bausch & Lomb |
|---|---|
| Address: | 3365 Tree Court Industrial Blvd. St. Louis, MO 63122 |
| Telephone #: | (636) 226-3183 |
| Fax #: | (636) 226-3245 |
| Official Correspondent: | Dennis Pozzo |
| Regulatory Affairs Specialist | |
| Date Summary Prepared: | May 25, 2004 |
| Device Name/ | |
| Proprietary name: | Phaco Chop Needle |
| Classification/Common Name | Phaco Needles |
| Class: | II |
| Panel: | Ophthalmic |
| Product Code: | HQC |
The marketed device(s) to which substantial equivalence is claimed: Bausch & Lomb Phaco Needles
PRODUCT DESCRIPTION:
The phacoemulsification (phaco) needle is the cylindrical, metal tip which is connected to the distal end of a phaco handpiece. The needle is the component of a phaco system which, as driven by the ultrasonic handpiece, contacts and fragments the cataractous crystalline lens. Irrigation fliud flows around the external surface of the needle into the eye. The emulsified lens material and irrigant are aspirated from the eye through the phaco needle lumen. The proposed Phaco Chop Needle has the same external and internal tip design as Bausch & Lomb's currently marketed MicroFlow and MicroFlow Plus Needles. However, the internal restriction is deeper within the needle bore
Substantial Equivalent Basis
The proposed Phaco Chop Needle is substantially equivalent to the reusable Phaco Needles currently offered by Bausch & Lomb. They are the Standard Phaco Needle, MicroFlow Phaco Needle, MicroFlow+ Phaco Needle
1
Comparison Matrix
| Components | Currently Marketed
Standard Phaco
Needle | Currently Marketed
MicroFlow Needle | Currently Marketed
MicroFlow Plus
Needle | Proposed Phaco
Chop Needle |
|---------------------|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Intended Use | Phaco needles are
used for anterior
segment surgery with
Bausch and Lomb
Microsurgical
Systems | Phaco needles are
used for anterior
segment surgery with
Bausch and Lomb
Microsurgical
Systems. | Phaco needles are
used for anterior
segment surgerv
with Bausch and
Lomb Microsurgical
Systems. | Phaco needles are
used for anterior
segment surgery with
Bausch and Lomb
Microsurgical
Systems |
| Sterile/Non-Sterile | Sterile & Non-Sterile | Sterile & Non-Sterile | Sterile & Non-Sterile | Non-Sterile only |
| Single Use/Reusable | Single Use & Reusable | Single Use & Reusable | Single Use & Reusable | Reusable only |
| Tip Angle (degrees) | 15, 30 & 45 | 0, 15, 30 & 45 | 0, 15, 30 & 45 | 30 & 45 |
| Needle Tip OD (in.) | 0.042 | 0.042 | 0.046 | 0.042 |
| Needle Tip ID (in.) | 0.036 | 0.036 | 0.036 | 0.036 |
Statement of Indications for Use
The Phaco Needles are intended for use with a Bausch & Lomb Millennium, Protegé or Premiere Microsurgical System for the emulsification of an opacified crystalline lens.
.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes above a wavy line.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 6 2004
Bauch & Lomb, Inc. c/o Dennis Pozzo 3365 Tree Ct. Industrial Blvd. St. Louis, MO 63122-6694
Re: K041998
Trade/Device Name: Phaco Chop Needles Regulation Number: 21 CFR 886.4670 Regulation Name: Phacoemulsification Needles Regulatory Class: Class II Product Code: HQC Dated: July 22, 2004 Received: July 26, 2004
Dear Mr. Pozzo:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 910(t) presidentially equivalent (for the indications felerenced above and nave determined in marketed predicate devices marketed in interstate for use stated in the encrosule) to regars nearment date of the Medical Device American be of Draw commerce private to May 20, 1976, the encordance with the provisions of the Federal Food, Drug. devices that have occh recuired in access approval of a premarket approval application (PMA). and Costlience Act (Act) that to not require apt to the general controls provisions of the Act. The You may, merefore, manse the device, belyer to the one of the series for annual registration, listing of general controls provisions of the rest 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 If your device is classified (see above) ins. Existing major regulations affecting your device can Inay oc subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of reants concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I Driseantes over device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of ally rederal statutes and regalations annualing, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807), adomig (21 CFR Part 820); and if applicable, the electronic form in the quality by techno (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Dennis Pozzo
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and anyon your e FDA finding of substantial equivalence of your device to a legally premainted predicated 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 (301) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A halpi korenthal
A. Ralph Rosenthal, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(K) Number
Device Name: Phaco Chop Needle
Indications for Use:
The Phaco Needles are intended for use with a Bausch & Lomb Millennium, Protegé or Premiere Microsurgical System for the emulsification of an opacified crystalline lens.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Over-the-Counter Use Prescription Use __ V
(Division Sign-Off)
Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number_ K 041998
510(k) Number k 041998
Bausch & Lomb Surgical