(26 days)
No
The document describes a mechanical implant (shoulder prosthesis) and its components, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a reverse total shoulder replacement designed to treat pain and dysfunction from conditions like severe arthropathy, failed joint replacements, fractures, bone defects, and various forms of arthritis. Its purpose is to alleviate symptoms and restore function, classifying it as a therapeutic device.
No
Explanation: The device is a reverse total shoulder replacement system, which is an implant used for treatment, not for diagnosing medical conditions.
No
The device description clearly describes a physical implantable medical device (a total shoulder prosthesis) and its components (humeral stems, glenoid baseplate, polyethylene inserts). There is no mention of software as the primary or sole component of the device.
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 surgical implant for replacing a damaged shoulder joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the components of a shoulder prosthesis, which is a physical implant used in surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue) or providing information for diagnosis.
- Performance Studies: The performance studies described are related to the mechanical integrity and function of the implant (fatigue tests, disassembly tests), not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to treat a condition, not to diagnose it.
N/A
Intended Use / Indications for Use
The Catalyst R1 Reverse Shoulder System is a reverse total shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:
- · Severe arthropathy with a grossly deficient rotator cuff;
- · Previously failed joint replacement with a grossly deficient rotator cuff;
- Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
- · Bone defect in proximal humerus;
- · Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural head and/or glenoid:
- · Inflammatory arthritis including rheumatoid arthritis;
- · Correction of functional deformity
The humeral stems are intended for cemented or uncemented applications.
The glenoid baseplate is intended for uncemented use with the addition of screws for fixation.
Product codes
PHX
Device Description
The Catalyst OrthoScience R1 Reverse Shoulder System is a total shoulder prosthesis designed for use in patients with a non-functional rotator cuff. The articulation of this reverse design is inverted compared to a traditional anatomic total shoulder prosthesis, where the articulating sphere is on the glenoid side of the joint, and the mating insert is fixed into the humeral stem implant. This submission is to add polyethylene inserts with a modified locking ring to the R1 Reverse Shoulder System. These polyethylene inserts are a design modification of the polyethylene inserts cleared in K202611 and K211991. There are no changes to the articulating interface or overall dimensions of the construct in vivo, the only change is to the locking mechanism. These polyethylene inserts do not replace the standard polyethylene inserts cleared in K202611 and K211991 but are an additional option and are compatible with all components within the Catalyst R1 Reverse Shoulder System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Construct fatigue tests were completed, and post fatigue tests included axial and torsional disassembly tests. The results of these tests indicate that the performance of the Catalyst R1 Reverse Shoulder is adequate for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”
0
Image /page/0/Picture/0 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
September 20, 2023
Catalyst OrthoScience, Inc. Dale Davison Sr VP - Manufacturing and Product Development 14710 Tamiami Trail N. Naples, Florida 34110
Re: K232583
Trade/Device Name: Catalyst R1 Reverse Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX Dated: August 23, 2023 Received: August 25, 2023
Dear Dale Davison:
We have reviewed vour 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. 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 located 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
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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.
Farzana
Sharmin -S
Digitally signed by
Farzana Sharmin -S
Date: 2023.09.20
17:02:08 -04'00'
Farzana Sharmin, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Catalyst R1 Reverse Shoulder System
Indications for Use (Describe)
The Catalyst R1 Reverse Shoulder System is a reverse total shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:
- · Severe arthropathy with a grossly deficient rotator cuff;
- · Previously failed joint replacement with a grossly deficient rotator cuff;
- Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
- · Bone defect in proximal humerus;
- · Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural head and/or glenoid:
- · Inflammatory arthritis including rheumatoid arthritis;
- · Correction of functional deformity
The humeral stems are intended for cemented or uncemented applications.
The glenoid baseplate is intended for uncemented use with the addition of screws for fixation.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| 510(k) Summary | |
|---|---|
| Prepared: | September 19, 2023 |
| Submitter: | Catalyst OrthoScience, Inc. |
| 14710 Tamiami Trail North, Suite 102 | |
| Naples, FL 34110 | |
| Contact: | Dale Davison |
| Sr. VP of Manufacturing & Product Development | |
| Catalyst OrthoScience, Inc. | |
| 1-239-325-9976 ext. 102 | |
| ddavison@catalystortho.com | |
| Proprietary Name: | Catalyst R1 Reverse Shoulder System |
| Common Name: | Shoulder Prosthesis |
| Classification Name: | 21 CFR 888.3660 - Shoulder joint metal/polymer semi-constrained |
| cemented prosthesis | |
| Regulatory Class: | Class II |
| Product Code: | PHX – Shoulder Prosthesis, Reverse Configuration |
| Primary Predicate: | Catalyst R1 Reverse Shoulder System K211991 |
| Additional Predicate: | TORNIER (Stryker) Aequalis Ascend Flex Shoulder System |
| K151293 |
Device Description:
The Catalyst OrthoScience R1 Reverse Shoulder System is a total shoulder prosthesis designed for use in patients with a non-functional rotator cuff. The articulation of this reverse design is inverted compared to a traditional anatomic total shoulder prosthesis, where the articulating sphere is on the glenoid side of the joint, and the mating insert is fixed into the humeral stem implant. This submission is to add polyethylene inserts with a modified locking ring to the R1 Reverse Shoulder System. These polyethylene inserts are a design modification of the polyethylene inserts cleared in K202611 and K211991. There are no changes to the articulating interface or overall dimensions of the construct in vivo, the only change is to the locking mechanism. These polyethylene inserts do not replace the standard polyethylene inserts cleared in K202611 and K211991 but are an additional option and are compatible with all components within the Catalyst R1 Reverse Shoulder System.
4
Intended Use / Indications For Use:
The Catalyst R1 Reverse Shoulder System is a reverse total shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:
- · Severe arthropathy with a grossly deficient rotator cuff;
- · Previously failed joint replacement with a grossly deficient rotator cuff;
- · Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
- · Bone defect in proximal humerus;
- · Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid;
- · Inflammatory arthritis including rheumatoid arthritis;
- Correction of functional deformity
The humeral stems are intended for cemented or uncemented applications.
The glenoid baseplate is intended for uncemented use with the addition of screws for fixation.
Comparison of Technologies:
The polyethylene inserts with modified locking rings are substantially equivalent to the predicate device regarding intended use and indications, size ranges, and design intent. Any noted differences do not raise different questions of safety and effectiveness.
Performance Data / Non-Clinical Testing:
Construct fatigue tests were completed, and post fatigue tests included axial and torsional disassembly tests. The results of these tests indicate that the performance of the Catalyst R1 Reverse Shoulder is adequate for its intended use.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Catalyst R1 Reverse Shoulder System polyethylene inserts with modified locking ring to the predicate device.
5
Conclusions
The Catalyst R1 Reverse Shoulder System polyethylene inserts with modified locking rings are substantially equivalent to the predicate device. The subject device has the same design features, uses the same materials, has the same intended use and indications, has the same size ranges, and the same design intent as the predicate devices. Any noted differences do not raise different questions of safety and effectiveness. The tests performed and results indicate the subject device is substantially equivalent to the predicate device.