(14 days)
Not Found
No
The description focuses on the mechanical and fluidic aspects of a phacoemulsification handpiece and explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes
The device is described as an accessory for a phacoemulsification system, intended for use in cataract surgery to "breakup, emulsify and extract the cataract," which directly treats a medical condition.
No
The device is described as an accessory for a phacoemulsification system, intended for use in cataract surgery to "breakup, emulsify and extract the cataract." This indicates a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly states it is a "handpiece" which is a physical hardware component used in surgery. It describes its physical characteristics and function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in cataract surgery to breakup, emulsify and extract the cataract." This describes a surgical procedure performed directly on a patient's eye, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a surgical handpiece that uses mechanical oscillation and fluid pathways for a surgical procedure. It does not describe a device used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
Therefore, the Benjamin ENVOY Hand Piece is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HQC
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.
-
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
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
9 2002 SEP
510(K) SUMMARY (as required by 807.92(c))
| Submitter of 510(k): | Benjamin Biomedical, Inc.
3125 Tyrone Blvd.
St. Petersburg, FL 33710
Phone: 727-343-5503
Fax: 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.
-
- 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.
1
| PARAMETER | BENJAMIN
ENVOY | STORZ
PREMIERE™ |
|----------------------|----------------------------------------|--------------------|
| Intended use | Phacofragmentation | Same |
| Design | Piezoelectric
Transduction | Same |
| Materials | Titanium, Silicone,
Stainless steel | Same |
| Operating frequency | 28 kHz | Same |
| Qty. piezocrystals | 2 | Same |
| Sterilization method | Steam only | Same |
| Host system | Premiere™ and
Protégé™ | 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.
2
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.
3
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
4
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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)