STERILS SINGLE-USE I/A HANDPIECES

K073023 · Bausch & Lomb, Inc. · HQC · Mar 12, 2008 · Ophthalmic

Device Facts

• Record ID: K073023
• Device Name: STERILS SINGLE-USE I/A HANDPIECES
• Applicant: Bausch & Lomb, Inc.
• Product Code: HQC · Ophthalmic
• Decision Date: Mar 12, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bausch & Lomb™ Sterile Single-Use I/A Handpieces are used following phacoemulsification, an anterior surgical procedure to fragment and remove a cataractous lens. The eye is infused with Balanced Salt Solution (BSS) via the irrigation function, while the cortical material, viscoelastic, and excess BSS is removed via the aspiration. I/A handpieces are also used for polishing the capsular bag to remove residual lens epithelial cells from the capsular membrane following extraction of the lens material.

Device Story

Sterile single-use irrigation/aspiration (I/A) handpieces; accessories to Bausch & Lomb Stellaris Vision Enhancement and PREMIERE (Millennium) Microsurgical Systems. Device features molded plastic handle with stainless steel tips; straight, curved, angled, or hooked configurations. Operates by simultaneous irrigation (Balanced Salt Solution) and aspiration (cortical material, viscoelastic, excess fluid) to maintain anterior chamber depth. Used in ophthalmic surgery by physicians; enables single-incision access to reduce ocular trauma. Single-use design eliminates reprocessing requirements. Output is physical removal of lens material and maintenance of chamber stability during cataract surgery.

Clinical Evidence

Bench testing only. No clinical data. Testing included sterilization validation (gamma irradiation, SAL 10^-6), seal integrity (dye penetration), microbial barrier testing, and biocompatibility (cytotoxicity, bioburden, LAL endotoxin, particle testing). All results within acceptable limits.

Technological Characteristics

Medical grade plastic handle; medical grade stainless steel tips. Single-use. Sterilized via gamma irradiation (SAL 10^-6). Compatible with B&L Stellaris and PREMIERE systems. Tip configurations: straight, curved, angled, hooked. Some models utilize silicone irrigation sleeves.

Indications for Use

Indicated for patients undergoing phacoemulsification for cataractous lens removal; used for irrigation, aspiration of cortical material/viscoelastic/BSS, and capsular bag polishing.

Regulatory Classification

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.

Predicate Devices

• Storz I/A Handpieces (K951463)
• SITE Microsurgical System (K912739)

Submission Summary (Full Text)

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### 510(k) Summary Statement Bausch & Lomb Irrigation and Aspiration Handpieces

MAR 12 2008

#### Applicant's Name and Address

Bausch & Lomb, Inc. 1400 North Goodman Street Rochester, NY 14609

Contact Person

Lisa Graney Global Regulatory and Quality Manager Bausch & Lomb. Inc. 1400 North Goodman Street Rochester, NY 14609 [phone]

#### 1. Identification of device

Common Name: Irrigation/Aspiration (I/A) Handpieces Trade Name: Bausch & Lomb® Sterile Single-Use I/A Handpieces Classification: Class II Phacofragmentation system (21 CFR 886.4670 Device classification: Class II (21 CFR 886.4670) Pro Code: 86 HQC

#### 2. Description of device

The Bausch & Lomb, Inc. Sterile Single-Use I/A Handpieces are accessories to the Bausch & Lomb, Inc. Stellaris Vision Enhancement System and the Bausch & Lomb, Inc. PREMIERE (Millennium) Microsurgical System. Both irrigation and aspiration functions are incorporated within one molded plastic handle, and operate simultaneously at a balanced rate to irrigate, maintain proper anterior chamber depth during a procedure, and remove cortical lens material, viscoelastic, and excess BSS used to bathe the anterior chamber. This combination feature allows access through a single incision, thus reducing trauma to the eye and improving surgical control. The Bausch & Lomb, Inc. family of Sterile Single-Use I/A Handpieces (containing the new plastic hand-held handle) currently consists of the models identified in Table 2.

#### 3. Intended use

The Bausch & Lomb Sterile Single-Use I/A Handpieces are used following phacoemulsification, an anterior surgical procedure to fragment and remove a cataractous lens. The eye is infused with Balanced Salt Solution (BSS) via the irrigation function, while the cortical material, viscoelastic, and excess BSS is removed via the aspiration function. I/A handpieces are also used for polishing the capsular bag to remove residual lens epithelial cells from the capsular membrane following extraction of the lens material.

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#### 4. Substantial Equivalence

| 510(k) | Clearance Date | Device Description |
|---------|----------------|----------------------------|
| K951463 | 10/27/1995 | Storz I/A Handpieces (B&L) |
| K912739 | 4/7/2006 | SITE Microsurgical System |

A comparison of characteristics of the Bausch & Lomb, Inc., Sterile Single-Use I/A Handpieces to those of predicate devices, demonstrating substantial equivalence is found at the end of this document.

#### 5. Technological Characteristics

The Bausch & Lomb, Inc., Sterile Single-Use I/A handpieces associated with this submission are a series of single handpieces, with different tip designs. One of the models requires a silicone irrigation sleeve. The handpiece tip configurations available are: straight, curved, and hooked designs. The microsurqical system for which the handpieces are designed include the Bausch & Lomb, Inc., Stellaris Vision Enhancement System and the Bausch & Lomb, Inc., PREMIERE Millenium Microsurgical System. The finished product material composition is a plastic medical grade handle, and medical grade stainless steel tips on the models. The handpieces are for single use purposes.

#### 6. Safety and Perfomance Testing:

Bausch & Lomb, Inc., Sterile Single-Use I/A Handpieces are provided Steriltv: sterile by gamma irradiation. Sterilization has been validated to a SAL of 10° for all standard panel of ophthalmic organisms in accordance with ANSI/AAMI/ISO TR13409 Standards.

Stability: Seal Integrity Test with dye penetration of radiated product; and a Microbial Barrier Test after accelerated aging at one and five years, in accordance with adopted Standards.

Biocompatibility: The following tests were conducted on the devices: cytotoxicity., bioburden determination, LAL Endotoxin Test, and Particle Test. All tests were conducted on three separate lots of product manufactured at different times. The results indicated that all outcomes were within expected and acceptable limits of the tests.

All stability and biocompatibility testing was conducted under adopted international standards as follows:

| Dye Penetration: | ANSI/AAMI/ISO 11607 (Annex C) |
|--------------------------|---------------------------------------------------|
| Microbial Barrier Test: | DIN 58953-6, DIN EN 868-1; ANSI/AAMI/ISO 11607 |
| Cytotoxicity: | DIN EN ISO 10993-5-12, ISO 9363-1 |
| Bioburden Determination: | DIN EN 1174, ISO 11737-1, USP 25 [61] |
| LAL Endotoxin Test: | DAB 1999 V.2, USP 25 [85], EP 2001, FDA Guideline |
| Particle Test: | USP 25 [788] |

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#### Bausch & Lomb, Inc. 510(k) Summary: Sterile Single-Use I/A Handpieces

Verification and Validation Testing: Performance testing was conducted on the devices and their components in accordance with device design control requirements and found to meet requirements set forth in the design control plan.

#### 7. Packaging

The Bausch & Lomb Inc., Sterile Single-Use I/A Handpieces are packaged in sealed packages subject to radiation sterilization and enclosed in an outer carton, labeled on the carton and the immediate package container.

#### 8. Clinical Data:

The Bausch & Lomb, Inc., Sterile Single-Use I/A Handpieces are substantially equivalent to Bausch & Lomb Inc., I/A handpieces currently available in the marketplace. Clinical investigations were deemed as not necessary for the planned marketing of the new model handpieces.

### 9. See following pages

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### Bausch & Lomb, Inc. 510(k) Summary: Sterile Single-Use I/A Handpieces

| MANUFACTURER | B&L I/A<br>HANDPIECES<br>[Subject 510(k)] | STORZ (B&L) I/A<br>HANDPIECES<br>K961463 | SITE MICROSURGICAL<br>SYSTEM<br>K912739 |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The Bausch &<br>Lomb™ Sterile<br>Single-Use I/A<br>Handpieces are<br>used following<br>phacoemulsification,<br>an anterior surgical<br>procedure to<br>fragment and<br>remove a<br>cataractous lens.<br>I/A handpieces are also<br>used for polishing the<br>capsular bag. | Irrigation/aspiration<br>of lens material<br>and viscoelastic<br>material; capsule<br>polishing: Models<br>B4973 and<br>B4973CAV for<br>viscoelastic<br>material removal<br>specifically | Irrigation/aspiration:<br>Models MVS1082 and<br>E4750121 infusion<br>handpieces for use in<br>bimanual procedures<br>specifically |
| Type of<br>handpiece/components | See Table 2. | See Table 2. | See Table 2. |
| -Number of single<br>handpieces | 23 | 13 | 10 |
| -Number of handpieces<br>for use with<br>interchangeable tips | 0 | 0 | 1 |
| -Number of<br>interchangeable tips | 0 | 0 | unknown |
| Models requiring a<br>silicone irrigation<br>sleeve | 85785S | MVS 1066 | none |
| Handpiece tip<br>configurations | Straight, curved,<br>angled, and hooked<br>designs | Straight, curved,<br>angled, and<br>hooked designs | Straight and curved<br>designs |
| Microsurgical system<br>for which handpieces<br>are designed | B&L Stellaris Vision<br>Enhancement<br>System and B&L<br>PREMIERE<br>Millenium<br>Microsurgical<br>System. | Storz Protégé and<br>PREMIERE for<br>MVS Models:<br>Storz DAISY and<br>United Sonics unit<br>for B4973;<br>Cavitron unit for<br>B4973 CAV. | SITE TXR Microsurgical<br>System 2200 |
| Finished Product<br>Material Composition | Medical grade<br>plastic handle;<br>medical grade<br>stainless steel on<br>most models | 316L, stainless<br>steel; medical<br>grade silicone on<br>most models | Stainless steel; other<br>materials unknown |
| Handpiece Reusable | No | Yes | Yes |

# 9. Table 1. Comparison Chart of Predicate Devices

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Table 2. Sterile Single-Use Handpieces and Corresponding Predicate Reusable I/A Handpieces

| | Sterile Single Use I/A Handpieces | | Predicate Reusable I/A Handpiece | | |
|-----------|--------------------------------------------------|-------------|-------------------------------------------------------|---------------|--|
| Model No. | Type | Model No. | Type | 510(k) number | |
| | Coaxial Irrigation/Aspiration Handpieces | | | | |
| 35782S | I/A Handpiece, straight, 17GA, 12/box | MVS 1063 | I/A Handpiece Straight, 17GA | K951463 | |
| 35783S | I/A Handpiece, curved, 17GA, 12/box | MVS 1063 S | I/A Handpiece Curved, 17GA | K951463 | |
| 35783ST | I/A Handpiece, curved, 17GA, 12/box | MVS 1063 S | I/A Handpiece Curved, 17GA | K951463 | |
| 35784S | I/A Handpiece, tip 45°, 17GA, 12/box | MVS 1063 CX | I/A Handpiece Tip 45°, 17GA | K951463 | |
| 35784ST | I/A Handpiece, tip 45°, 17GA, 12/box | MVS 1063 CX | I/A Handpiece Tip 45°, 17GA | K951463 | |
| 35785S | I/A Handpiece, straight with sleeve, 12/box | MVS 1066 | I/A Handpiece, straight with sleeve | K951463 | |
| 35786S | I/A Handpiece, tip 90°, 16GA, 12/box | DP9730 | I/A Tip 90° for use with handle DP9721 | K951463 | |
| 35786ST | I/A Handpiece, tip 90°, 16GA, 12/box | DP9730 | I/A Tip 90° for use with handle DP9721 | K951463 | |
| 35794ST | I/A Handpiece curved with Sleeve 1.8 12/box | DP9734 | Curved I/A Tip with sleeve for use with DP9721 Handle | K951463 | |
| 35795ST | I/A Handpiece tip 45° with Sleeve 1.8 12/box | DP9733 | 45° I/A Tip with sleeve for use with DP9721 Handle | K951463 | |
| | Bimanual Aspiration Handpieces | | | | |
| 35780S | Aspiration Handpiece, sterile, 21GA, 12/box | E4753A23 | Aspiration Handpiece, 0.3mm Port | K912739 | |
| 35901S19 | Aspiration Handpiece, 19GA, 12/box | MVS1083 | Aspiration Handpiece, 19GA | K912739 | |
| 35901S20 | Aspiration Handpiece, 20GA, 12/box | MVS1083 | Aspiration Handpiece, 19GA | K912739 | |
| | Bimanual Irrigation Handpieces | | | | |
| 35781S | Irrigation Handpiece, sterile, 21GA, 12/box | E4750I21 | Irrigation Handpiece 21GA | K912739 | |
| 35787S | Irrigation Handpiece, smooth tip, 21GA, 12/box | E4750I21 | Irrigation Handpiece 21GA | K912739 | |
| 35787ST | Irrigation Handpiece, smooth tip, 21GA, 12/box | E4750I21 | Irrigation Handpiece 21GA | K912739 | |
| 35788S | Irrigation Handpiece, central port, 21GA, 12/box | E4750I21 | Irrigation Handpiece 21GA | K912739 | |
| 35902S19 | Irrigation Handpiece, 19GA, 12/box | MVS1082 | Irrigation Handpiece, 19GA | K912739 | |
| 35902S20 | Irrigation Handpiece, 20GA, 12/box | MVS1082 20 | Irrigation Handpiece, 20GA | K912739 | |
| 35902ST19 | Irrigation Handpiece, 19GA, 12/box | MVS1082 | Irrigation Handpiece, 19GA | K912739 | |
| | Bimanual Irrigation Choppers | | | | |
| 35903S19 | Irrigation Chopper, 19GA, 12/box | MVS1096 19 | Irrigation Chopper, 19GA | K951463 | |
| 35903S20 | Irrigation Chopper, 20GA, 12/box | MVS1096 19 | Irrigation Chopper, 19GA | K951463 | |
| 35903ST19 | Irrigation Chopper, 19GA, 12/box | MVS1096 19 | Irrigation Chopper, 19GA | K951463 | |

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bausch & Lomb, Inc. c/o Ms. Lisa Graney Manager, Global Regulatory Affairs 1400 North Goodman St. Rochester, NY 14609

MAR 1 2 2008

Re: K073023

Trade/Device Name: Bausch & Lomb (B&L) Sterile Single-Use I/A Handpieces Regulation Number: 21 CFR 886.4670 Regulation Name: Phacofragmentation System Regulatory Class: Class II Product Code: HQC Dated: February 19, 2008 Received: February 21, 2008

Dear Ms. Graney:

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Malina B. Eglata, und

Malvina B. Eydelman, M.I Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Bausch & Lomb, Inc. B&L Sterile Single-Use I/A Handpieces

Indication for Use

Section 4

#### SECTION 4 : INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _KO 13023

Device Name:

Bausch & Lomb™ Sterile Single-Use I/A Disposable Handpieces

Indication for Use

The Bausch & Lomb™ Sterile Single-Use I/A Handpieces are used following phacoemulsification, an anterior surgical procedure to fragment and remove a cataractous lens. The eye is infused with Balanced Salt Solution (BSS) via the irrigation function, while the cortical material, viscoelastic, and excess BSS is removed via the aspiration. I/A handpieces are also used for polishing the capsular bag to remove residual lens epithelial cells from the capsular membrane following extraction of the lens material.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the -counter-use

M.L.B. Nichols

(Division Sign-off)
Division of Ophthalmic Devices

510(k) Number K073023

ਨੇਤ

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# BAUSCH & LOMB STERILE SINGLE-USE I/A STELLARIS HANDPIECE MODELS 510(K) K073023

、

| Model No.<br>Sterile Single Use I/A Handpieces | Type |
|------------------------------------------------|-------------------------------------------|
| Coaxial Irrigation/Aspiration Handpieces | |
| 85782S | I/A Handpiece Straight, 17GA |
| 85783S | I/A Handpiece, curved, 17 GA |
| 85783ST | I/A Handpiece, curved, 17 GA |
| 85784S | I/A Handpiece, tip 45°, 17 GA |
| 85784ST | I/A Handpiece, Tip 45°, 17 GA |
| 85785S | I/A Handpiece, straight w/ sleeve |
| 85786S | I/A Handpiece, tip 90°, 16 GA |
| 85786ST | I/A Handpiece, tip 90°, 16 GA |
| 85794ST | I/A Handpiece, curved w/ Sleeve 1.8 |
| 85795ST | I/A Handpiece |
| Bimanual Aspiration Handpieces | |
| Sterile Single-Use I/A Handpiece<br>Model No. | Type |
| 85780S | Aspiration Handpiece, sterile, 21 GA |
| 85901S19 | Aspiration Handpiece, sterile, 19 GA |
| 85901S20 | Aspiration Handpiece, sterile, 20 GA |
| Bimanual Irrigation Handpieces | |
| Sterile Single-Use I/A Handpiece<br>Model No. | Type |
| 85781S | Irrigation Handpiece, sterile, 21 GA |
| 85787S | Irrigation Handpiece, smooth tip, 21 GA |
| 85787ST | Irrigation Handpiece, smooth tip, 21 GA |
| 85788S | Irrigation Handpiece, central port, 21 GA |
| 85902S19 | Irrigation Handpiece, sterile, 19 GA |
| 85902S20 | Irrigation Handpiece, sterile, 20 GA |
| 85902ST19 | Irrigation Handpiece, sterile, 19 GA |
| Bimanual Irrigation Choppers | |
| Sterile Single-Use I/A Handpiece | Type |
| Model No. | |
| 85903S19 | Irrigation Chopper, 19 GA |
| 85903S20 | Irrigation Chopper, 20 GA |
| 85903ST19 | Irrigation Chopper, 19 GA |

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