(93 days)
Not Found
No
The document describes a system for arthroscopic procedures involving fluid management, shaving, and RF energy. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies. The performance studies focus on mechanical, electrical, and biological aspects of the device.
Yes
The device is indicated for use in orthopedic and arthroscopic procedures, including resection, debridement, and coagulation of tissues, which are therapeutic interventions.
Yes.
The "Intended Use / Indications for Use" section states: "The Fluid Management System of the Relign Arthroscopic System provides fluid distension of the knee, shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures." This explicitly mentions diagnostic procedures.
No
The device description explicitly states it is a "combination radiofrequency controller, shaver system, and fluid management system" comprised of multiple hardware components including a controller, handpiece, blades, probes, and fluid management accessories.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system used for surgical procedures (arthroscopy) involving fluid management, tissue resection, debridement, and coagulation within the body. This is an in vivo application, not an in vitro (outside the body) diagnostic test.
- Device Description: The description details components like a shaver handpiece, blades, probes, and fluid pumps, all designed for direct interaction with tissues and fluids during surgery.
- Lack of Diagnostic Purpose: The system's function is therapeutic and procedural (removing tissue, managing fluid, achieving hemostasis), not for diagnosing a condition by analyzing samples outside the body.
- No Mention of Samples or Assays: There is no mention of collecting biological samples (blood, urine, tissue samples) or performing any kind of assay or analysis on them.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Relign Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Relign Arthroscopic System provides fluid distension of the knee, shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures. The Shaver Blade/RF Probe of the Relign Arthroscopic System provides abrasion, resection, debridement, and removal of bone through its shaver blade; removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels through its shaver blade and 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI, HRX
Device Description
The Relign Arthroscopic System is a combination radiofrequency controller, shaver system, and fluid management system. The integrated system simultaneously controls a reusable shaver handpiece with disposable shaver blades and probes that include electrosurgical energy, as well as fluid management through inflow and outflow pumps that operate on the peristaltic principle. The system is comprised of five (5) major system components: The Relign Controller that includes a Footswitch, a reusable Shaver Handpiece, a disposable sterile single-use Combination Shaver Blade, a disposable sterile single-use Reciprocating RF Probe, and a disposable sterile single-use Fluid Management Accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, ankle, elbow, wrist and hip
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Performance Data: The Relign Arthroscopic System performance was tested in accordance with design specifications and with voluntary external standards. Performance testing to design specifications included: flow rate testing, pressure control testing, electrode temperature and coagulation depth testing, mechanical testing, durability testing, simulated use testing, cadaver testing, distribution testing, and shelf life testing. The bench testing performed on the Relign Arthroscopic System verifies that the device satisfies design specifications and acceptance criteria.
Software: Software was developed, tested, and verified per FDA guidance documents and IEC 62304:2006.
Electrical Safety and EMC: Electrical safety and electromagnetic compatibility testing were verified per IEC 60601-1:2005, IEC 60601-2-2:2009, and IEC 60601-1-2:2014.
Biocompatibility: The biocompatibility of the patient contacting materials of the Relign Arthroscopic System, specifically the Shaver Handpiece, Combination Shaver Blade. Reciprocating RF probe and Fluid Management Accessories component devices, was assessed in accordance with ISO 10993:2009 and FDA’s "Guidance for Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, 16 June 2016." Biocompatibility was demonstrated based on the results of biological assessment and testing performed on the materials.
Sterilization: The sterile disposable devices were validated for use with Gamma Irradiation in accordance with VDmax method as outlined in ANSI/AAMI/ISO 11137-2:2013. The results were found to be acceptable, thus substantiating that the minimum sterilization dose evaluated provides a SAL of 10-6. The Relign Shaver Handpiece was validated for use with STERRAD sterilization. The low temperature plasma sterilization process was validated in accordance with the "Overkill Sterilization Method" per AAMI TIR12:2010 and ISO 14937:2009. The results were found to be acceptable, thus substantiating that each sterilization cycle evaluated provides a SAL of 10-6.
Human Factors: Pursuant to FDA’s Guidance, "Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design", Human Factors testing was performed on the Relign Arthroscopic System. Both Formative and Summative Testing were conducted to determine whether users trained per the IFU were able to set-up and operate the Relign Arthroscopic System. User testing demonstrated that the users were able to successfully execute the test scenarios without failures.
Conclusion: The minor differences in the design between the Relign Arthroscopic System and the predicate devices do not raise any new types of safety or effectiveness questions as confirmed by design verification testing.
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
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, layered on top of each other. The profiles are black, and the text is also in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 4, 2017
ReLIGN Corporation Mr. Nathan Nguyen Sr. Director, Quality Assurance & Regulatory Affairs 1601 South De Anza Boulevard. Suite 200 Cupertino, California 95014
Re: K162770
Trade/Device Name: ReLIGN Arthroscopic System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, HRX Dated: December 2, 2016 Received: December 5, 2016
Dear Mr. Nguyen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Jennifer R. Stevenson -A
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162770
Device Name
Relign Arthroscopic System
Indications for Use (Describe)
The Relign Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Relign Arthroscopic System provides fluid distension of the knee, shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures. The Shaver Blade/RF Probe of the Relign Arthroscopic System provides abrasion, resection, debridement, and removal of bone through its shaver blade; removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels through its shaver blade and 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for ReLIGN Corporation. The word "ReLIGN" is written in a bold, sans-serif font, with "Re" in blue and "LIGN" in black. Below the word "ReLIGN" is the word "CORPORATION" written in a smaller, thinner, sans-serif font. The letters in "CORPORATION" are gray.
510(k) Summary
1. Date Prepared: December 22, 2016
2. Submitter Name and Address:
ReLIGN Corporation 1601 South De Anza Boulevard, Suite 200 Cupertino, CA 95014 Phone: (408) 996-2517 Ext. 320 Fax: (408) 642-1455
Contact: Nathan Nguyen, Sr. Director, Quality Assurance & Regulatory Affairs
3. Device Name:
| Trade Name: | Relign Arthroscopic System |
|---|---|
| Common Name(s): | Arthroscope and Electrosurgical Cutting & Coagulation |
| Device and Accessories; Arthroscopic Pump, Tubing | |
| Sets and Accessories | |
| Classification Name(s): | Electrosurgical Cutting and Coagulation Device and |
| Accessories (21 CFR 878.4400); and Arthroscope and | |
| Accessories (21 CFR 888.1100) | |
| Product Code: | GEI, HRX |
Predicate Devices: 4.
| K071859 | Stryker Crossfire Integrated Arthroscopy System |
|---|---|
| K123441 | Stryker CrossFlow Integrated Arthroscopy Pump |
5. Device Description:
The Relign Arthroscopic System is a combination radiofrequency controller, shaver system, and fluid management system. The integrated system simultaneously controls a reusable shaver handpiece with disposable shaver blades and probes that include electrosurgical energy, as well as fluid management through inflow and outflow pumps that operate on the peristaltic principle. The system is comprised of five (5) major system components: The Relign Controller that includes a Footswitch, a reusable Shaver Handpiece, a disposable sterile single-use Combination Shaver Blade, a disposable sterile single-use Reciprocating RF Probe, and a disposable sterile single-use Fluid Management Accessories.
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Image /page/4/Picture/0 description: The image shows the logo for ReLIGN Corporation. The first two letters, "Re", are in blue, while the rest of the letters are in black. Below the word ReLIGN is the word "CORPORATION" in a smaller, light gray font. The logo is simple and modern.
Indications for Use: 6.
The Relign Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Relign Arthroscopic System provides fluid distension and irrigation of the knee, shoulder, ankle, elbow, wrist and hip, and fluid suction during diagnostic and operative arthroscopic procedures. The Shaver Blade/RF Probe of the Relign Arthroscopic System provides abrasion, resection, debridement, and removal of bone through its shaver blade; removal, ablation, and coaqulation of soft tissue; as well as hemostasis of blood vessels through its shaver blade and probe. Examples of uses of the product include resection of torn knee cartilage, subacromial decompression, and resection of synovial tissue in other ioints.
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.
7. Technological Characteristics
The Relign Arthroscopic System is substantially equivalent to the predicate devices. The Relian Controller provides control to the Fluid Management Accessories to deliver fluid under pressure control to the joint, control to the Shaver Handpiece for arthroscopic shaving and bone burring, and RF power through the shaver handpiece into the RF shaver blades/probes. The Shaver Handpiece is an electrically powered, hand-held surgical instrument that uses interchangeable shaver blades/probes to abrade and remove bone and debride soft tissue. The Shaver Handbiece has RF contacts which connect to the shaver blades/probes to deliver RF to the tissue sufficient for the resection, ablation, and coagulation of soft tissue within the joint. The Shaver Handpiece features hand switches for controlling shaver parameters, a screen providing visual indication of shaver parameters, and a suction irrigation port for removing fluid and tissue from the operating site. The shaver blade/probe is an arthroscopic shaver blade that provides abrasion, resection, debridement, and removal of bone; removal, ablation, and coagulation of soft tissue; as well as hemostasis of blood vessels. The Fluid Management Accessories provides control of the infusion and outflow of fluids within the joint space. Fundamentally, the Relign Arthroscopic System simply combines well-known and understood device types into one integrated system to abrade, resect, debride, and remove bone; remove, ablate and coagulate soft tissues; as well as provide hemostasis of blood vessels.
8. Bench Performance Data
The Relign Arthroscopic System performance was tested in accordance with design specifications and with voluntary external standards. Performance testing to design specifications included: flow rate testing, pressure control testing, electrode temperature and coaqulation depth testing, mechanical testing, durability testing, simulated use testing, cadaver testing, distribution testing, and shelf life testing. The bench testing performed on the Relign Arthroscopic System verifies that the device satisfies design specifications and acceptance criteria. Software was developed, tested, and verified per FDA guidance
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Image /page/5/Picture/1 description: The image shows the logo for ReLIGN Corporation. The word "ReLIGN" is written in a stylized font, with the "Re" in blue and the "LIGN" in black. Below the word "ReLIGN" is the word "CORPORATION" in a smaller, gray font. The logo is simple and modern, and the use of color helps to make it stand out.
documents and IEC 62304:2006. Electrical safety and electromagnetic compatibility testing were verified per IEC 60601-1:2005, IEC 60601-2-2:2009, and IEC 60601-1-2:2014. The biocompatibility of the patient contacting materials of the Relign Arthroscopic System, specifically the Shaver Handpiece, Combination Shaver Blade. Reciprocating RF probe and Fluid Management Accessories component devices, was assessed in accordance with ISO 10993:2009 and FDA's "Guidance for Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, 16 June 2016." Biocompatibility was demonstrated based on the results of biological assessment and testing performed on the materials. The sterile disposable devices were validated for use with Gamma Irradiation in accordance with VDmax method as outlined in ANSI/AAMI/ISO 11137-2:2013. The results were found to be acceptable, thus substantiating that the minimum sterilization dose evaluated provides a SAL of 10°. The Relign Shaver Handpiece was validated for use with STERRAD sterilization. The low temperature plasma sterilization process was validated in accordance with the "Overkill Sterilization Method" per AAMI TIR12:2010 and ISO 14937:2009. The results were found to be acceptable, thus substantiating that each sterilization cycle evaluated provides a SAL of 10°. Pursuant to FDA's Guidance, "Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design", Human Factors testing was performed on the Relign Arthroscopic System. Both Formative and Summative Testing were conducted to determine whether users trained per the IFU were able to set-up and operate the Relign Arthroscopic System. User testing demonstrated that the users were able to successfully execute the test scenarios without failures. The minor differences in the design between the Relign Arthroscopic System and the predicate devices do not raise any new types of safety or effectiveness questions as confirmed by design verification testing.
9. Substantial Equivalence
Based on the results of the Bench Performance, Biocompatibility, Cadaver Studies and Usability Testing, the Relign Arthroscopic System with integrated functionality is substantially equivalent to the currently cleared Stryker Crossfire RF and Shaver System (K071859) and Stryker CrossFlow Integrated Arthroscopy Pump (K123441) with respect to intended use/indication for use, technological characteristics, and principles of operation. The minor differences in the design between the Relign Arthroscopic System and the predicate devices do not raise any new types of safety or effectiveness questions as confirmed by design verification testing. Therefore, the Relign Arthroscopic System is substantially equivalent to the previously-cleared predicate devices.
The following comparison tables show the similarities and differences regarding the technological characteristics of the subject and the predicate devices:
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| Table 9-1: Radiofrequency Comparison | ||
|---|---|---|
| Feature | Subject Device | Predicate Device |
| Relign Arthroscopic System | Stryker Crossfire | |
| Bipolar Ablation Radiofrequency | Yes | Same |
| RF Max Power (W) | 400W | Same |
| RF peak Voltage (V) | 500V | 400V |
| RF Frequency(kHz) | 225kHz | 200kHz |
| Waveform | Square Wave | Same |
| Crest Factor |