(74 days)
No
The description focuses on mechanical function and electrical safety, with no mention of AI/ML terms or capabilities.
No
The input describes a surgical device used for tissue resection, shaving, and abrading during arthroscopic procedures, not a device intended for therapy or treatment of a disease.
No
This device is designed for surgical tissue resection and abrading, not for diagnosing medical conditions. It is a therapeutic device.
No
The device description explicitly states it is a reusable, non-sterile, AC powered device composed of stainless steel and aluminum, indicating it is a hardware device.
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 "arthroscopic surgical procedures where intra-articular tissue resection, shaving, and/or abrading the knee or shoulder joint is required." This describes a surgical tool used directly on the patient's body during a procedure.
- Device Description: The description reinforces this by detailing a "reusable, non-sterile, AC powered device" used in "arthroscopic surgical procedures." It also mentions the handpiece having "only a brief and incidental contact with the patient."
- Lack of IVD Characteristics: An IVD device is designed to examine specimens from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological samples.
The device described is a surgical instrument used for mechanical manipulation of tissue within a joint during surgery.
N/A
Intended Use / Indications for 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).
Product codes
Not Found
Device 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 visualization utilizing a separate port of entry (incision site). Blades and drills are available separately and are not included in this Premarket Notification. The modified handpiece is composed of 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee or shoulder joint
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PowerCut® Gold Battery Powered Surgical System (K863696)
Reference Device(s)
Dyonics PS3500, Stryker SE3, Linvatec Concepts IntraArc®
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
0
Image /page/0/Picture/0 description: The image shows the logo for Baxter Surgical Group. The word "Baxter" is in a bold, italicized font. Below it, in a smaller, non-bold font, are the words "Surgical Group."
Baxter Healthcare Corporation 1500 Waukegan Road, Bldg. K McGaw Park, Illinois 60085 USA
708.473.1500 FAX: 708.785.2460
AUG - 5 1996
962022
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: | (847) 785-3322 |
| 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:
Intended Use:
Substantial Equivalence:
Summary of Testing:
v suarzat o novi strižing a sebarate port of entry (incision site). Blades and drills are available separately and are not included in this Premarket Notification.
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).
The Modified PowerCut® Gold Surgical System is substantially equivalent to the following commercially marketed surgical power devices:
-
- V. Mueller PowerCut® Gold Surgical System K863696
-
- Dyonics PS3500
-
- Stryker SE3
-
- Linvatec Concepts IntraArc®
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:
Intended Use:
Substantial Equivalence:
Summary of Testing:
visualization utilizing a separate port of entry (incision site). Blades and drills are available separately and are not included in this Premarket Notification.
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 ioint is required. The system is used in conjunction with direct arthroscopic camera visualization utilizing a separate port of entry (incision site).
The Modified PowerCut® Gold Surgical System is substantially equivalent to the following commercially marketed surgical power devices:
-
- V. Mueller PowerCut® Gold Surgical System K863696
-
- Dyonics PS3500
-
- Stryker SE3
-
- Linvatec Concepts IntraArc®
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.