(26 days)
Not Found
No
The description focuses on the mechanical and ultrasonic aspects of phacoemulsification and does not mention any AI or ML components.
Yes
The device is used for phacoemulsification, which is a surgical procedure to remove cataracts, directly treating a medical condition.
No
The device is used for surgical removal of an opacified lens (phacoemulsification), which is a treatment procedure, not a diagnostic one.
No
The device description clearly states it is a "Disposable Pack" and an "accessory to the Millennium, Premiere and Protege Microsurgical Systems," which are hardware systems. It also mentions an "electronically driven handpiece." This indicates the device includes physical components, not just 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 the device is for the "phacoemulsification of an opacified crystalline lens during anterior segment surgery." This is a surgical procedure performed directly on the patient's eye.
- Device Description: The description details a surgical accessory used to break down and remove a cataract from the eye. It describes a physical process (ultrasonic disintegration, irrigation, aspiration) performed on tissue within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVDs are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as part of a surgical procedure.
N/A
Intended Use / Indications for Use
The Venturi Phaco Packs are intended for use with a Bausch & Lomb Millennium, Protege or Premiere microsurgical system for the phacoemulsification of an opacified crystalline lens during anterior segment surgery.
Product codes (comma separated list FDA assigned to the subject device)
HQC
Device Description
The Bausch & Lomb (B&L) Phacoemulification Disposable Packs are an accessory to the Millennium, Premiere and Protege Microsurgical Systems for use in performing phacoemulsification procedures. Phacoemulsification involves the ultrasonic disintegration of the opacified crystalline lens (cataract) from the eye. This process is accomplished by means of an electronically driven handpiece which: 1) emulsifies the lens, 2) facilitates the irrigation of the anterior chamber and 3) facilitates the aspiration of the emulsified lens material and irrigant from the eve
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior segment (of the 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): 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
DEC 1 7 2003
Venturi Phaco Packs
510(k) SUMMARY (per 21 CFR §807.92)
| Submitter's Name:
Address: | Bausch & Lomb
3365 Tree Court Industrial Blvd.
St. Louis, MO 63122 |
|-----------------------------------|--------------------------------------------------------------------------|
| Telephone #:
Fax #: | (636) 226-3183
(636) 226-3245 |
| Official Correspondent: | Dennis Pozzo
Regulatory Affairs Specialist |
| Date Summary Prepared: | November 13, 2003 |
| Device Name/
Proprietary name: | Venturi Phaco Packs |
| Classification/Common Name | Phaco Packs |
| Class: | II |
| Panel: | Ophthalmic |
| Product Code: | HQC |
The marketed device(s) to which substantial equivalence is claimed: Venturi Phaco Packs
PRODUCT DESCRIPTION:
The Bausch & Lomb (B&L) Phacoemulification Disposable Packs are an accessory to the Millennium, Premiere and Protege Microsurgical Systems for use in performing phacoemulsification procedures. Phacoemulsification involves the ultrasonic disintegration of the opacified crystalline lens (cataract) from the eye. This process is accomplished by means of an electronically driven handpiece which: 1) emulsifies the lens, 2) facilitates the irrigation of the anterior chamber and 3) facilitates the aspiration of the emulsified lens material and irrigant from the eve
Substantial Equivalent Basis
The modified DP4310 and new DP4305 Venturi Phaco Packs are substantially equivalent to the existing DP4310 (K955901) and DP4330 and DP4345 (combination K952259). See Comparison Matrix.
1
Comparison Matrix
| Components | Currently Marketed
DP4310 Pack | Currently Marketed
DP4330 & DP4345
Pack | Proposed DP4310
Pack | Proposed DP4305
Pack |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Collection Cassette | X | X | X | X |
| I/A Tube Set | X | X | X | X |
| Test Chamber | X (2ea) | X (2ea) | X (1ea) | X (1ea) |
| Irrigation Sleeve | X (2ea.) | X (2ea.) | X (2ea.) | X (1ea.) |
| Needle Wrench | X | X | X | X |
| Filter Irrigation
Administration Set | X | X | X | X |
| Tray Support Cover | X | X | X | X |
| Auxiliary Drape | X | X | X | X |
| Cassette Stopper and
Cap | X | X | X | X |
| Remote Control Drape | X | X | X | X |
| Instructions
(Directions for Use) | X | X | X | X |
| Phaco Needle | | X | | |
| 2.5mm Slit Knife | | X | | |
| Components | Currently Marketed
DP4310 Pack | Currently Marketed
DP4330 & DP4345
Pack | Proposed DP4310
Pack | Proposed DP4305
Pack |
| Intended Use | Phaco packs used for
anterior segment
surgery with Bausch
and Lomb
Microsurgical
Systems, such as the
Millennium, Protégé,
and Premiere. | Phaco packs used for
anterior segment
surgery with Bausch
and Lomb
Microsurgical
Systems, such as the
Millennium, Protégé,
and Premiere. | Phaco packs used for
anterior segment
surgery with Bausch
and Lomb
Microsurgical
Systems, such as the
Millennium, Protégé,
and Premiere. | Phaco packs used for
anterior segment
surgery with Bausch
and Lomb
Microsurgical
Systems, such as the
Millennium, Protégé,
and Premiere. |
| Sterilization
Method | Gamma | Gamma | Gamma | Gamma |
| Sterility Assurance
Level | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ |
| Single Use | Yes | Yes | Yes | Yes |
2
Statement of Indications for Use
The Venturi Phaco Packs are intended for use with a Bausch & Lomb Millennium, Protege or Premiere microsurgical system for the phacoemulsification of an opacified crystalline lens during anterior segment surgery.
3
Image /page/3/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three wing-like shapes above a wavy line, representing water or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 7 2003
Bausch & Lomb, Inc. c/o Mr. Dennis Pozzo Regulatory Affairs Specialist 3365 Tree Court Industrial Blvd. St. Louis, MO 63122
Re: K033653
Trade/Device Name: Venturi Phaco Pack Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation system Regulatory Class: Class II Product Code: HQC Dated: November 18, 2003 Received: November 21, 2003
Dear Mr. Pozzo:
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 four d 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.
4
Page 2 - Mr. Dennis Pozzo
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 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 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
Enclosure
5
510(K) Number – K033653
Device Name: Venturi Phaco Pack
Indications for Use:
The Venturi Phaco Packs are intended for use with a Bausch & Lomb Millennium, Protegé or Premiere microsurgical system for the phacoemulsification of an opacified crystalline lens during anterior segment surgery.
(Please do not write below this line - continue on another Page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| OR Over-the-Counter Use |
| (Division Sign-Off) | Clay R. Buttemere |
|---|---|
| (Division Sign Off) | |
| Division of Ophthalmic Ear, Nose and Throat Cavities |
| 510(k) Number | K033 |
|---|---|
| --------------- | ------ |
| Bausch & Lomb Surgical | 510(k) Number |
|---|---|
| ------------------------ | --------------- |