(29 days)
Not Found
No
The summary describes a standard arthroscopic system with fluid management and shaver/RF probe components. The changes described relate only to sterilization methods. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used for therapeutic procedures such as "abrasion, resection, debridement, and removal of bone," as well as "ablation, and coagulation of soft tissue," and "hemostasis of blood vessels." These actions are direct interventions to treat conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Fluid Management System provides "fluid suction during diagnostic and operative arthroscopic procedures."
No
The device description explicitly mentions hardware components like a Fluid Management System, Shaver Blade/RF Probe, and Shaver Handpiece, and the performance studies focus on the sterilization and reprocessing of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for surgical procedures (arthroscopy) involving fluid management, tissue resection, debridement, and hemostasis. These are all actions performed on the patient's body during surgery.
- Device Description: The description focuses on the components of a surgical system, specifically a shaver handpiece and its sterilization methods.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, or tissue.
The device is clearly intended for use in vivo (within the body) during surgical procedures.
N/A
Intended Use / Indications for Use
The Relign Tricera Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Relign Tricera 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 Tricera 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 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 device description for the modified device is identical to the device description of the predicate device cleared per K162770 with the exception of the sterilization methods for Relign's Shaver Handpiece, a component device of the Tricera Arthroscopic System, which is being changed as follows:
Current Methods: STERRAD 100S, STERRAD 100NX, STERRAD NX
Proposed Methods: Steris V-PRO Lumen, Steam Autoclave
New Available Methods: STERRAD 100S, STERRAD 100NX, STERRAD NX, Steris V-PRO Lumen, Steam Autoclave
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, and other joints.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The newly proposed sterilization methods for Relign's Shaver Handpiece were validated in accordance with the "Overkill Sterilization Method" per AAMI TIR12:2010 and ISO 14937:2009. The performance testing has validated that the cycle parameters of each sterilization cycle evaluated are safe and effective and able to achieve an SAL of 10to when processing Relign's Shaver Handpiece. In addition, the analysis results of the sterilization residuals indicated that the maximum residual levels and tolerable contact limits were below the levels defined in the protocol acceptance criteria.
Reprocessing functionality testing was also repeated with the newly proposed autoclave steam sterilization method in order to verify that Relign's Shaver Handpiece is able to successfully withstand the exposure of anticipated reprocessing conditions. The results of the verification indicated that the device was able to maintain its performance for the estimated duration of expected use, confirming that there are no new functional risks introduced from the proposed autoclave steam sterilization method when compared to the predicate (K162770) device (R-10002 Shaver Handpiece).
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.
0
November 28, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Relign Corporation Nathan Nguyen Director, Quality and Regulatory Affairs 655 Campbell Technology Parkway Suite 275 Campbell, California 95008
Re: K233493
Trade/Device Name: Tricera Arthroscopic System: Tricera Controller (R-10001): Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014); Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012); Curved Standard Shaver 3.4mm (R-10024) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, HRX Dated: October 27, 2023 Received: October 30, 2023
Dear Nathan 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sara S. Thompson -S
For
Jesse Muir, Ph.D. Assistant Director
2
DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
K233493
Device Name
Tricera Arthroscopic System; Tricera Controller (R-10001): Tricera Shaver Handpiece (R-10023); Veriflow (R-10003); Exoflow (R-10017); 3-in-1 Shaver 4.2mm (R-10008); 3-in-1 Shaver 5.0mm (R-10014): Dynablator (R-10005); Standard Burr (R-10021); Standard Shaver 3.4mm (R-10012): Curved Standard Shaver 3.4mm (R-10024)
Indications for Use (Describe)
The Relign Tricera Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Relign Tricera 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 Tricera 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 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
Image /page/4/Picture/0 description: The image shows the Zimmer Biomet logo. The logo consists of a blue circle with a stylized "Z" inside it, followed by the text "ZIMMER BIOMET" in a simple, sans-serif font. The logo is clean and modern, and the blue color gives it a sense of trustworthiness and reliability.
655 Campbell Technology Parkway, Suite 275 · Campbell, CA 95008 USA · ☎ 408.484.7599
Special 510(k) Summary
K233493 Page 1 of 3
-
- Date Prepared: October 27, 2023
2. Sponsor Name and Address:
Relign Corporation, a subsidiary of Zimmer Biomet 655 Campbell Technology Parkway, Suite 275 Campbell, CA 95008 USA Phone: 408-484-7428 Fax: 408-740-3071
Contact: Nathan Nguyen, Director, Quality Assurance & Regulatory Affairs
3. Device Name:
| Trade Name: | Tricera™ Arthroscopic System |
|---|---|
| Common Name: | Arthroscope and Electrosurgical Cutting & Coagulation |
| Device and Accessories | |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and |
| Accessories (21 CFR 878.4400) | |
| Product Code: | GEI, HRX |
4. Predicate Device:
| Trade Name: | Relign Arthroscopic System |
|---|---|
| Common Name: | Arthroscope and Electrosurgical Cutting & Coagulation |
| Device and Accessories | |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and |
| Accessories (21 CFR 878.4400) | |
| Product Code: | GEI, HRX |
| 510(K) Number: | K162770 |
5. Device Description:
The device description for the modified device is identical to the device description of the predicate device cleared per K162770 with the exception of the sterilization methods for Relign's Shaver Handpiece, a component device of the Tricera Arthroscopic System, which is being changed as follows:
| Current Methods | Proposed Methods | New Available Methods |
|---|---|---|
| STERRAD 100S | STERRAD 100S | |
| STERRAD 100NX | STERRAD 100NX | |
| STERRAD NX | STERRAD NX | |
| Steris V-PRO Lumen | Steris V-PRO Lumen | |
| Steam Autoclave | Steam Autoclave |
5
Image /page/5/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a white "Z" inside of it. To the right of the circle is the text "ZIMMER BIOMET" in a sans-serif font. The text is also blue, matching the color of the circle and the "Z".
655 Campbell Technology Parkway, Suite 275 · Campbell, CA 95008 USA · ☎ 408.484.7599
K233493 Page 2 of 3
6. Indications for Use:
The Relign Tricera Arthroscopic System is indicated for use in orthopedic and arthroscopic procedures. The Fluid Management System of the Relign Tricera 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 Tricera 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 electrosuraical 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 proposed modification does not change the fundamental design, operating principles and the intended/indications for use of Relign's Tricera Arthroscopic System. Therefore, the technological characteristics of the modified device remain substantially equivalent to that of the predicate device (K162770). The modified Tricera Arthroscopic System is substantially equivalent to the legally marketed predicate device Tricera Arthroscopic System (K162770) in that these devices are identical in use, utilize similar materials, and operate using the same fundamental design principles.
8. Performance Data
The newly proposed sterilization methods for Relign's Shaver Handpiece were validated in accordance with the "Overkill Sterilization Method" per AAMI TIR12:2010 and ISO 14937:2009. The performance testing has validated that the cycle parameters of each sterilization cycle evaluated are safe and effective and able to achieve an SAL of 10to when processing Relign's Shaver Handpiece. In addition, the analysis results of the sterilization residuals indicated that the maximum residual levels and tolerable contact limits were below the levels defined in the protocol acceptance criteria.
Reprocessing functionality testing was also repeated with the newly proposed autoclave steam sterilization method in order to verify that Relign's Shaver Handpiece is able to successfully withstand the exposure of anticipated reprocessing conditions. The results of the verification indicated that the device was able to maintain its performance for the estimated duration of expected use, confirming that there are no new functional risks introduced from the proposed autoclave steam sterilization method when compared to the predicate (K162770) device (R-10002 Shaver Handpiece).
6
Image /page/6/Picture/0 description: The image contains the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a simple sans-serif font. The text is also in blue, matching the color of the circle and the "Z" symbol.
655 Campbell Technology Parkway, Suite 275 · Campbell, CA 95008 USA · ☎ 408.484.7599
9. Conclusions
K233493 Page 3 of 3
Relign concludes that the latest modified (subject) Tricera Autoclavable Shaver Handpiece (R-10023) remains substantially equivalent to the 510(k)-cleared (K162770) Tricera Shaver Handpiece (R-10002) and does not have any adverse impact when used with Relign's Tricera Arthroscopic System. Furthermore, Relign's Tricera Arthroscopic System with modification is determined to remain substantially equivalent to the FDA-cleared (per K162770) Relign Arthroscopic System (a predicate device).