(77 days)
The Stryker Crossfire System is intended for use in orthopedic and arthroscopic procedures for the following joints: knee, shoulder, ankle, elbow, wrist, and hip. The Crossfire System provides abrasion, resection, debridement and removal of bone and soft tissue through its shaver blade; and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels, through its electrosurgical probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.
The Stryker Crossfire System consists of a console, footswitch, shaver handpiece and two possible disposable attachments (RF probe and shaver blade).
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. This document is a 510(k) summary for the Stryker Crossfire System, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance metrics through a study with acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the given text.
The document primarily states:
- Product Description: The Stryker Crossfire System consists of a console, footswitch, shaver handpiece, and two disposable attachments (RF probe and shaver blade).
- Indications for Use: Intended for orthopedic and arthroscopic procedures in various joints for abrasion, resection, debridement, bone and soft tissue removal (shaver blade), and ablation, coagulation, hemostasis of soft tissue and blood vessels (electrosurgical probe).
- Contraindications: Electrosurgical probe should not be used with nonconductive irrigants or in patients with pacemakers/electronic implants.
- Voluntary Safety and Performance Standards: The system conforms to numerous IEC, ISO, and EN standards.
- Predicate Devices: Stryker CORE (K032303), SERFAS Energy (K041810), and Total Performance Shaver (K973195) Systems.
- Substantial Equivalence: Claimed due to same intended use and no new questions of safety and effectiveness compared to predicate devices.
The FDA's letter confirms the substantial equivalence determination but does not detail specific performance studies.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Proprietary Name: | Stryker Crossfire System |
|---|---|
| Common and Usual Names: | RF and Shaver System |
| Classification Name: | Arthroscope (21 CFR 888.1100) and Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) |
SEP 2 0 2007Product Description: The Stryker Crossfire System consists of a console, footswitch, shaver handpiece and two possible disposable attachments (RF probe and shaver blade).
Indications for Use: The Stryker Crossfire System is intended for use in orthopedic and arthroscopic procedures for the following joints: knee, shoulder, ankle, elbow, wrist, and hip. The Crossfire System provides abrasion, resection, debridement and removal of bone and soft tissue through its shaver blade; and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels, through its electrosurgical probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other joints.
Contraindications: The electrosurgical probe should not be used in procedures where a nonconductive irrigant is used or with patients having cardiac pacemakers or other electronic implants.
Voluntary Safety and Performance Standards: The Stryker Crossfire System will conform to the following voluntary safety and performance standards including: EN 980, EN 1041, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 62304, IEC 60601-2-2, IEC 60529, G 95-1, ISO 10993-1, EN 550, EN 556-1, ISO 17664, ISO 11607-1, ISO 11607-2 and ISO 14971.
Predicate Devices: The Stryker Crossfire System is substantially equivalent in terms of safety and effectiveness to currently marketed devices including the Stryker CORE (K032303), SERFAS Energy (K041810), and Total Performance Shaver (K973195) Systems.
Substantial Equivalence: When compared to the predicated devices listed above, the Stryker Crossfire System has the same intended use and the technological differences do not raise new questions of safety and effectiveness. Therefore, the Stryker Crossfire System is substantially equivalent to the predicate marketed devices. Refer to Section 7.0 for a detailed comparison.
Contact:
K. Jeffrey Semone Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Phone: 408-754-2124 408-754-2521 Fax: Email: jeff.semone(@stryker.com Date:
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 0 2007
Stryker Endoscopy % Mr. K. Jeffrey Semone 5900 Optical Court San Jose, California 95138
Re: K071859
Trade/Device Name: Stryker Crossfire System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, HRX Dated: August 28, 2007 Received: August 29, 2007
Dear Mr. Semone:
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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Page 2 - Mr. K. Jeffrey Semone
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Ko 71859
INDICATIONS FOR USE
Device Name: Stryker Crossfire System
510(k) Number if known: K071859
The Stryker Crossfire System is intended for use in orthopedic and arthroscopic procedures for the following joints: knee, shoulder, ankle, elbow, wrist, and hip. The Crossfire System provides abrasion, resection, debridement and removal of bone and soft tissue through its shaver blade; and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels, through its electrosurgical probe. Examples of uses of the product include resection of torn knee cardiage, subacromial decompression, and resection of synovial tissue in other joints.
Contraindications:
The electrosurgical probe should not be used in procedures where a nonconductive irrigant is used or with patients having cardiac pacemakers or other electronic implants.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(a) Number 107185
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.