As an accessory for the Storz Premiere phacoemulsification system, the Benjamin ENVOY Hand Piece intended for use in cataract surgery to breakup, emulsify and extract the cataract.

Device Description

General: The handpiece uses a piezoelectric transduction method to longitudinally oscillate a cutting tip (not included with the device) at a resonant frequency of 28 kHz. The device has integral colinear irrigation and coaxial aspiration fluidic pathways.
Host Phacofragmentation System: The device is intended as a replacement for the phacofragmentation handpiece used on the Bausch and Lomb Premiere™ and Protégé™ phacofragmentation system consoles. These systems has been commercially available in the U.S. for approximately 10 years. To insure compatibility with the host system, the Envoy handpiece is designed to be equivalent to the original handpiece used on the previously mentioned systems.

AI/ML Overview

The provided text describes the 510(k) summary for the Benjamin ENVOY Phaco Handpiece. This document primarily focuses on establishing substantial equivalence to a predicate device, not on validating performance against detailed acceptance criteria through a clinical study in the typical sense of AI/ML device validation.

Therefore, many of the requested categories for a study that "proves the device meets the acceptance criteria" are not directly applicable to this type of submission. The document relies on comparative data and established technical specifications rather than human reader studies or large-scale outcome data.

Here's an attempt to populate the table and answer the questions based only on the provided text, highlighting where information is not available due to the nature of the submission:

1. Table of acceptance criteria and the reported device performance

Parameter	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (Benjamin ENVOY)
Intended Use	Phacofragmentation (Storz Premiere™)	Phacofragmentation (Same)
Design	Piezoelectric Transduction (Storz Premiere™)	Piezoelectric Transduction (Same)
Materials	Titanium, Silicone, Stainless steel (Storz Premiere™)	Titanium, Silicone, Stainless steel (Same)
Operating frequency	28 kHz (Storz Premiere™)	28 kHz (Same)
Qty. piezocrystals	2 (Storz Premiere™)	2 (Same)
Sterilization method	Steam only (Storz Premiere™)	Steam only (Same)
Host system	Premiere™ and Protégé™ (Storz Premiere™)	Premiere™ and Protégé™ (Same)
Biocompatibility	Meets ISO 10993-1 (Storz Premiere™)	Meets ISO 10993-1 (Same)
Patient contact	Indirect (fluids) (Storz Premiere™)	Indirect (fluids) (Same)
Device setup	Connect tubing, Tip installation, System connection (Storz Premiere™)	Connect tubing, Tip installation, System connection (Same)

Study Information Pertaining to Device Acceptance (Based on 510(k) Submission)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of a clinical test set as described for AI/ML devices. The "test" here is a technical comparison to a predicate device.
- Data Provenance: The data is a comparison of technical specifications and design features against a legally marketed predicate device (Storz Premiere™). It's not "data provenance" in the sense of clinical study data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth in this context refers to the established specifications and performance of the predicate device, which is a regulatory and engineering assessment rather than expert clinical consensus on a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no clinical adjudication for a test set. The comparison is based on engineering design and performance characteristics.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done. This device is a surgical handpiece, not an AI/ML diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical/electronic surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for demonstrating substantial equivalence is the established performance, design, materials, and intended use of the legally marketed predicate device (Storz Premiere™ Microsurgical System, K946227). This is an engineering and regulatory "truth" rather than a clinical one.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML algorithm was used.

Summary of the Study Proving Acceptance Criteria:

The "study" presented here is a comparison to a predicate device to demonstrate substantial equivalence, which is the basis for 510(k) clearance.

The Benjamin ENVOY Phaco Handpiece is described as being equivalent in design, materials, operating frequency, sterilization method, and compatibility with host systems to the Storz Premiere™ Microsurgical System handheld phacofragmentation device (K946227). The manufacturer states that the Envoy handpiece is designed to be "equivalent to the original handpiece used on the previously mentioned systems" (Bausch and Lomb Premiere™ and Protégé™ phacofragmentation system consoles).

Specifically, the device meets acceptance by:

Sharing the exact same intended use (phacofragmentation for cataract surgery).
Utilizing the same piezoelectric transduction design.
Being constructed of the same materials (Titanium, Silicone, Stainless steel).
Operating at the same frequency (28 kHz) with the same number of piezocrystals (2).
Requiring the same sterilization method (Steam only).
Being compatible with the same host systems (Premiere™ and Protégé™).
Meeting biocompatibility standards (ISO 10993-1), identical to the predicate.
Having the same type of patient contact (indirect via fluids).
Requiring similar device setup procedures.

The FDA's letter (K022833) confirms that based on this comparison, the device is substantially equivalent to legally marketed predicate devices, thereby allowing it to proceed to market. There are no clinical trial data, human reader studies, or AI/ML algorithm performance metrics provided or required for this type of submission for this specific medical device.

Summary

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9 2002 SEP

K022833

510(K) SUMMARY (as required by 807.92(c))

Submitter of 510(k):	Benjamin Biomedical, Inc.3125 Tyrone Blvd.St. Petersburg, FL 33710Phone: 727-343-5503Fax: 727-343-4637
Contact Person:	Joe Morrison
Date of Summary:	July 2, 2002
Trade Name:	Benjamin ENVOY Phaco Handpiece
Classification Name:	Unit, Phacofragmentation
Predicate Device:	Storz Premiere ® Microsurgical System K946227

Intended Use:

As an accessory for the Storz Premiere phacoemulsification system, the Benjamin ENVOY Hand Piece intended for use in cataract surgery to breakup, emulsify and extract the cataract.

Device Description:

The Envoy is a Class II phacofragmentation handpiece device per 886.4670 of 21 1. General: The handpiece uses a piezoelectric transduction method to longitudinally oscillate a CFR. cutting tip (not included with the device) at a resonant frequency of 28 kHz. The device has integral colinear irrigation and coaxial aspiration fluidic pathways.
1. Host Phacofragmentation System: The device is intended as a replacement for the phacofragmentation handpiece used on the Bausch and Lomb Premiere™ and Protégé™ phacofragmentation system consoles. These systems has been commercially available in the U.S. for approximately 10 years. To insure compatibility with the host system, the Envoy handpiece is designed to be equivalent to the original handpiece used on the previously mentioned systems.

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PARAMETER	BENJAMINENVOY	STORZPREMIERE™
Intended use	Phacofragmentation	Same
Design	PiezoelectricTransduction	Same
Materials	Titanium, Silicone,Stainless steel	Same
Operating frequency	28 kHz	Same
Qty. piezocrystals	2	Same
Sterilization method	Steam only	Same
Host system	Premiere™ andProtégé™	Same
Biocompatibility	Meets ISO 10993-1	Same
Patient contact	Indirect (fluids)	Same
Device setup	Connect tubing1	Same
	Tip installation2	Same
	System connection3	Same

PHACO HANDPIECE COMPARISON SUMMARY

1 Male and Female non-locking luer fittings.

2 #4-40 UNC-2B threaded connection.

3 Multi-contact electrical connector.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest the head, body, and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 9 2002

Benjamin Biomedical, Inc. c/o Mr. Mark Job TUV America, Inc. 1775 Old Highway 8 New Brighton, MN 55112-1891

Re: K022833

Trade/Device Name: Benjamin Envoy Phoco Handpiece Regulation Number: 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: II Product Code: HQC Dated: July 2, 2002 Received: August 26, 2002

Dear Mr. Job:

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.

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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.

A. Ralph Rosenthal

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

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510(k) Number (if known): KO22833

Benjamin ENVOY Phaco Handpeice Device Name:

Indications For Use:

As an accessory for the Storz Premiere phacoemulsification system, the Benjamin ENVOY Hand Piece intended for use in cataract surgery to breakup, emulsify and extract the cataract.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Euretta Reese

Onhthalmic

510(k) Number K022833

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.