(33 days)
No
The summary describes a mechanical implant and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is a reverse shoulder prosthesis designed to treat severe shoulder arthropathy and rotator cuff deficiency, which are medical conditions, thereby providing a therapeutic effect.
No
The device is a reverse shoulder prosthesis designed for the surgical treatment of severe shoulder arthropathy. It is an implantable medical device, not a diagnostic tool.
No
The device description explicitly states it is made of physical components (titanium alloy, polyethylene, stainless steel) and is provided sterile, indicating it is a physical implant, not software.
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 surgical implant for treating shoulder conditions. It involves replacing a joint and addressing issues with the rotator cuff. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The description details the materials and components of a physical implant designed to be placed within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information about a patient's health status.
The device is a surgical implant used in a therapeutic procedure.
N/A
Intended Use / Indications for Use
The ARROW Off-Centred Humeral Insert is designed for the following indications:
REVERSE PROSTHESIS (POROUS GLENOID IMPLANT)
The ARROW Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented or cementless application while the porous glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.
Product codes
PHX
Device Description
The ARROW Off-Centered Humeral Insert is used for reverse shoulder prosthesis, with implants of Arrow Reverse Shoulder System (K112193 and K150568), similar to the standard version. This is a modification of the standard ARROW reverse prosthesis (K122193), with the purpose of reducing lateralization of the prosthesis, increase the range of motion, and provide better adaptation for patient anatomy. The ARROW Off-Centered Humeral Insert is made up of four components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, polyethylene UHMWPE per ASTM F648/ISO 5834-1, and stainless steel 316L per ASTM F138/ISO 5832-1, identical to the previous ARROW Humeral Insert cleared in the 510(k) file ARROW Reverse Shoulder System (K112193). All components are provided sterile via gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
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
Sterilization (ISO 11137), packaging (ISO 11607), and biocompatibility (ISO 10993-1), and bacterial endotoxin (LAL) validations and rationales were conducted and provided to demonstrate substantial equivalence.
Mechanical performance testing and analysis, including connection between stem and humeral insert per ASTM F2009 and Range of Motion, reverse prosthesis per ASTM F1378 has been performed on the subject ARROWoff-centred Humeral Insert. The results have shown them to be substantially equivalent to the predicate devices.
The results of all mechanical tests have shown them to be substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
K112193, K150568, K122698, K171789, K132285
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 is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 29, 2023
FH Industrie % Christine Scifert Partner MRC Global, LLC 9085 E. Mineral Cir., Suite 110 Centennial, Colorado 80112
Re: K232226
Trade/Device Name: ARROW Off-Centred Humeral Insert Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX Dated: July 26, 2023 Received: July 27, 2023
Dear Christine Scifert:
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. 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: 2023.08.29
17:30:58-04'00'
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)
K232226
Device Name ARROW Off-Centred Humeral Insert
Indications for Use (Describe)
The ARROW Off-Centred Humeral Insert is designed for the following indications:
REVERSE PROSTHESIS (POROUS GLENOID IMPLANT)
The ARROW Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented or cementless application while the porous glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary FH Industrie ARROW Off-Centred Humeral Insert 29 August 2023
| Company: | FH INDUSTRIE
ZI DE KERNEVEZ-6 RUE NOBEL
QUIMPER Finistere, FRANCE 29000 |
|-------------------------|-----------------------------------------------------------------------------------------------------------|
| Company Contact: | Naoual RAHIMI- FH Industrie
Regulatory Affairs Manager
n.rahimi@fhortho.com
+33 (0)2 56 10 20 46 |
| Official Correspondent: | Christine Scifert – MRC Global, LLC
Christine.scifert@askmrcglobal.com
901-831-8053 |
| Trade Name: | ARROW Off-Centred Humeral Insert |
| Common Name: | Shoulder Prosthesis, Reverse Configuration |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3660 (Shoulder joint metal/polymer semi-constrained
cemented prosthesis) |
| Panel: | Orthopedic |
| Product Code: | PHX |
Device Description:
The ARROW Off-Centered Humeral Insert is used for reverse shoulder prosthesis, with implants of Arrow Reverse Shoulder System (K112193 and K150568), similar to the standard version. This is a modification of the standard ARROW reverse prosthesis (K122193), with the purpose of reducing lateralization of the prosthesis, increase the range of motion, and provide better adaptation for patient anatomy. The ARROW Off-Centered Humeral Insert is made up of four components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, polyethylene UHMWPE per ASTM F648/ISO 5834-1, and stainless steel 316L per ASTM F138/ISO 5832-1, identical to the previous ARROW Humeral Insert cleared in the 510(k) file ARROW Reverse Shoulder System (K112193). All components are provided sterile via gamma irradiation.
Indications for Use:
The ARROW Off-Centred Humeral Insert is designed for the following indications:
REVERSE PROSTHESIS (POROUS GLENOID IMPLANT)
4
Page 2 of 2 The ARROW Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cementless application while the porous glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.
Substantial Equivalence:
The subject ARROW Off-centred humeral insert components are substantially equivalent with respect to indications for use, design, dimension, and materials to the following devices, previously cleared by the FDA:
Primary Predicate:
Secondary Predicates:
- Tornier Aequalis ASCEND FLEX Shoulder System- K122698
- . FH Industrie: Arrow reverse Porous Glenoid: K171789
- . Tornier Aequalis Reversed Shoulder System - K132285
Instrument Biocompatibility Reference Device: ARROW Anatomical Shoulder System - K093599
The Indications for Use, Materials, and Dimensions for primary predicate are identical to those of the subject device with the exception of the offset of the humeral insert. Performance testing and analysis has shown the subject to perform as well as or better than the predicate devices. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.
Performance Testing:
Sterilization (ISO 11137), packaging (ISO 11607), and biocompatibility (ISO 10993-1), and bacterial endotoxin (LAL) validations and rationales were conducted and provided to demonstrate substantial equivalence.
Mechanical performance testing and analysis, including connection between stem and humeral insert per ASTM F2009 and Range of Motion, reverse prosthesis per ASTM F1378 has been performed on the subject ARROWoff-centred Humeral Insert. The results have shown them to be substantially equivalent to the predicate devices.
The results of all mechanical tests have shown them to be substantially equivalent to the predicate device.
Conclusion
Based on the test results and the comparison to the predicate device is determined to be substantially equivalent to the predicate device.