POWERCUT GOLD SURGICAL SYSTEM

K962022 · Baxter Healthcare Corp · HWE · Aug 5, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K962022
• Device Name: POWERCUT GOLD SURGICAL SYSTEM
• Applicant: Baxter Healthcare Corp
• Product Code: HWE · General, Plastic Surgery
• Decision Date: Aug 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Modified PowerCut® Gold Surgical System is designed for use in arthroscopic surgical procedures where intra-articular tissue resection, shaving, and/or abrading the knee or shoulder joint is required. The system is used in conjunction with direct arthroscopic camera visualization utilizing a separate port of entry (incision site).

Device Story

Reusable, AC-powered surgical system for arthroscopic procedures; used for intra-articular tissue resection, shaving, and abrading in knee or shoulder joints. Operates in conjunction with direct arthroscopic camera visualization via separate incision. System provides mechanical power to separately available blades and drills. Used by surgeons in clinical/OR settings. Output is mechanical rotation/torque for tissue manipulation; assists surgeon in precise tissue removal, potentially reducing procedure time and improving surgical outcomes.

Clinical Evidence

Bench testing only. Performance testing included 100% inspection of torque measurements at various RPMs against design requirements. Electrical safety and thermal protection verified per UL-544 and IEC 601. Biocompatibility supported by established history of medical-grade stainless steel and aluminum materials.

Technological Characteristics

AC-powered reusable surgical handpiece. Materials: medical-grade stainless steel and aluminum. Standards: UL-544, IEC 601 for electrical/thermal safety. Mechanical actuation for blades/drills. No software or electronic control algorithms described.

Indications for Use

Indicated for patients undergoing arthroscopic surgical procedures of the knee or shoulder joint requiring intra-articular tissue resection, shaving, or abrading.

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Predicate Devices

• PowerCut® Gold Battery Powered Surgical System (K863696)

Reference Devices

• Dyonics PS3500
• Stryker SE3
• Linvatec Concepts IntraArc®

Submission Summary (Full Text)

{0}

Baxter
Surgical Group
Baxter Healthcare Corporation
1500 Waukegan Road, Bldg. K
McGaw Park, Illinois 60085
USA
708.473.1500
FAX: [phone]

AUG - 5 1996
k962022

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS POWERCUT® GOLD SURGICAL POWER SYSTEM

## Appendix G

| Manufacturer: | Dagmar, Incorporated
5733 S. Laburnum Avenue
Richmond, Virginia 23231 |
| --- | --- |
| Regulatory Affairs Contact: | Maryalice Smith
Surgical Group
1500 Waukegan Road MPK
McGaw Park, IL |
| Telephone: | [phone] |
| Date Summary Prepared: | May 1996 |
| Common Name: | Modified PowerCut® Gold
Surgical System |
| Classification: | Class I per 21CFR § 878.4820 |
| Predicate Device: | PowerCut® Gold Battery
Powered Surgical System
(K863696) |
| Description: | The modified PowerCut® Gold Surgical system will be a reusable, non-sterile, AC powered device. It is designed for use in arthroscopic surgical procedures that require intra-articular tissue resection, shaving, and/or abrading of the knee or shoulder joint. The system is used in conjunction with direct arthroscopic camera |

{1}

Description:

V sora za. u i . . . izing a separate port of entry (incision site). Blades and drills are available separately and are not included in this Premarket Notification.

Intended Use:

The Modified PowerCut® Gold Surgical System is designed for use in arthroscopic surgical procedures where intra-articular tissue resection, shaving, and/or abrading the knee or shoulder joint is required. The system is used in conjunction with direct arthroscopic camera visualization utilizing a separate port of entry (incision site).

Substantial Equivalence:

The Modified PowerCut® Gold Surgical System is substantially equivalent to the following commercially marketed surgical power devices:

1. V. Mueller PowerCut® Gold Surgical System K863696
2. Dyonics PS3500
3. Stryker SE3
4. Linvatec Concepts IntraArc®

Summary of Testing:

Quality performance testing is conducted on 100% of finished product systems. Torque measurements are recorded at various RPM reading to ensure that torque parameters meet those specified in the System Design Requirements. Test samples passed all acceptance criteria established in the functional protocol testing. The modified PowerCut® Gold Surgical System has been tested to meet the Electrical Safety and Thermal protection requirements of UL-544 and IEC 601. Cleaning and sterilization of this reusable device have been validated and are included within the label copy. The modified handpiece is composed of

{2}

Description:

visualization utilizing a separate port of entry (incision site). Blades and drills are available separately and are not included in this Premarket Notification.

Intended Use:

The Modified PowerCut® Gold Surgical System is designed for use in arthroscopic surgical procedures where intra-articular tissue resection, shaving, and/or abrading the knee or shoulder joint is required. The system is used in conjunction with direct arthroscopic camera visualization utilizing a separate port of entry (incision site).

Substantial Equivalence:

The Modified PowerCut® Gold Surgical System is substantially equivalent to the following commercially marketed surgical power devices:

1. V. Mueller PowerCut® Gold Surgical System K863696
2. Dyonics PS3500
3. Stryker SE3
4. Linvatec Concepts IntraArc®

Summary of Testing:

Quality performance testing is conducted on 100% of finished product systems. Torque measurements are recorded at various RPM reading to ensure that torque parameters meet those specified in the System Design Requirements. Test samples passed all acceptance criteria established in the functional protocol testing. The modified PowerCut® Gold Surgical System has been tested to meet the Electrical Safety and Thermal protection requirements of UL-544 and IEC 601. Cleaning and sterilization of this reusable device have been validated and are included within the label copy. The modified handpiece is composed of

{3}

Summary of Testing:

various medical grades of stainless steel and aluminum, and have only a brief and incidental contact with the patient. These materials have a long and well-established history of biocompatibility.