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.

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

AI/ML Overview

This document describes a 510(k) submission for a new medical device, the Phaco Chop Needle, which is a variation of existing phacoemulsification needles used in cataract surgery. The submission claims substantial equivalence to previously marketed Bausch & Lomb Phaco Needles.

Analysis of Acceptance Criteria and Study Details:

Based on the provided information, this submission focuses on demonstrating substantial equivalence to existing, legally marketed devices rather than establishing novel performance criteria through a standalone clinical study with acceptance criteria.

The core of the submission is a comparison matrix that highlights the design similarities between the proposed Phaco Chop Needle and the predicate devices (Standard Phaco Needle, MicroFlow Needle, MicroFlow+ Needle). The key difference noted for the proposed device is that "the internal restriction is deeper within the needle bore" compared to its external and internal tip design, which is the same as the MicroFlow and MicroFlow Plus Needles.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with pre-defined performance thresholds does not directly apply to this 510(k) summary. Instead, the "acceptance criteria" here are implied to be that the device operates safely and effectively for its intended use, performing comparably to the predicate devices.

Here's how to interpret your request in the context of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (as demonstrated by comparison)
Intended Use Equivalence: Phaco needles are used for anterior segment surgery with Bausch and Lomb Microsurgical Systems for emulsification of an opacified crystalline lens.	Met: Proposed Phaco Chop Needle shares the identical "Indications for Use" statement with predicate devices: "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."
Design Feature Equivalence (External & Internal Tip): External and internal tip design should be similar to predicate devices to ensure comparable interaction with the crystalline lens.	Met: "The proposed Phaco Chop Needle has the same external and internal tip design as Bausch & Lomb's currently marketed MicroFlow and MicroFlow Plus Needles."
Material/Size Equivalence (Key Dimensions): Needle Tip OD and ID are critical for surgical performance and compatibility.	Met: - Needle Tip OD (in.): 0.042 (same as Standard and MicroFlow, MicroFlow+ is 0.046) - Needle Tip ID (in.): 0.036 (same as all predicates)
Operational Equivalence (Sterility/Reusability): Deviations from predicate in these areas need to be justified for safety.	Met (with specific differences acknowledged): - Sterile/Non-Sterile: Proposed is "Non-Sterile only" (Predicates are "Sterile & Non-Sterile"). This implies the device is intended for sterilization by the user. - Single Use/Reusable: Proposed is "Reusable only" (Predicates are "Single Use & Reusable"). This is a notable difference but likely addressed by demonstrating cleaning/sterilization protocols.
Tip Angle Options: Range of tip angles offered.	Met (with specific differences acknowledged): Proposed offers 30 & 45 degrees (Predicates offer wider ranges, e.g., 0, 15, 30, & 45). The offered angles are a subset of the predicate's range.
Safety and Effectiveness (overall implicit criteria): The device should not raise new questions of safety or effectiveness and be as safe and effective as the predicate devices.	Met (by FDA determination): The FDA's 510(k) clearance letter states, "We have determined in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that this 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." This is the ultimate "proof" in a 510(k) context.

2. Sample Size for the Test Set and Data Provenance:

Sample Size for Test Set: Not applicable in the context of a clinical performance study with a dedicated "test set" and a 510(k) for a device with a similar design and intended use to existing devices. The "test" here is largely the design comparison and potentially benchtop testing (which is not detailed in this summary). There is no mention of human subject testing (clinical trial) for this specific 510(k) submission.
Data Provenance: Not applicable. The "data" primarily consists of design specifications and a comparison table, rather than clinical data from a "test set."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. There is no mention of specific experts establishing ground truth for a clinical test set in this 510(k) summary. The "ground truth" for substantial equivalence is based on existing regulatory clearances of the predicate devices and internal engineering assessments by the manufacturer.

4. Adjudication Method for the Test Set:

Not applicable. There is no clinical test set requiring an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, as this is a device design submission, not an AI or diagnostic imaging product requiring human reader evaluation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

No, a standalone (algorithm only) performance study was not done. This device is a physical medical instrument, not an algorithm or AI.

7. The Type of Ground Truth Used:

The "ground truth" in this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices (Bausch & Lomb Standard Phaco Needle, MicroFlow Phaco Needle, MicroFlow+ Phaco Needle). The submission aims to demonstrate that the new device is sufficiently similar to these predicates that it shares their safety and effectiveness profile, as determined by the FDA. This is essentially regulatory precedent and engineering design comparison.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for a physical medical device.

Summary

{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 PozzoRegulatory 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:

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 MarketedStandard PhacoNeedle	Currently MarketedMicroFlow Needle	Currently MarketedMicroFlow PlusNeedle	Proposed PhacoChop Needle
Intended Use	Phaco needles areused for anteriorsegment surgery withBausch and LombMicrosurgicalSystems	Phaco needles areused for anteriorsegment surgery withBausch and LombMicrosurgicalSystems.	Phaco needles areused for anteriorsegment surgervwith Bausch andLomb MicrosurgicalSystems.	Phaco needles areused for anteriorsegment surgery withBausch and LombMicrosurgicalSystems
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

Regulation Number and Section

§ 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.