(369 days)
ARROW® Indications for Use: The anatomical shoulder system, depending on the components used, is designed for:
Simple humeral prosthesis:
- Fracture dislocation or complex four part fracture of the proximal humerus
- Humeral head necrosis without injury to the glenoid cavity.
- Extensive humeral head cartilage damage without injury to the glenoid cavity
- Centered osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
- Rheumatoid polyarthritis with thin rotator cuff.
- Off-centered osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.
Total anatomical prosthesis (cemented glenoid implant with 4 pegs)
AND/OR
- Centered glenohumeral osteoarthritis with functional rotator cuff
- Rheumatoid polyarthritis with functional rotator cuff
- Fracture sequela, functional rotator cuff with glenoid injury.
The ARROW® anatomical shoulder system is a modular shoulder prosthesis, composed of the following elements:
- humeral stems,
- humeral heads (centred or off-centred),
- cemented glenoids.
The ARROW® anatomical shoulder system is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.
The provided document is a 510(k) Premarket Notification for the ARROW® anatomical shoulder system, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or clinical outcomes through human studies with strict acceptance criteria based on metrics like sensitivity or specificity.
Therefore, many of the typical acceptance criteria and study design elements requested in the prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of device submission. The "acceptance criteria" here are related to demonstrating mechanical performance and biocompatibility sufficient to show equivalence.
However, I can extract the information that is present and indicate where the requested information is not provided or applicable given the nature of a 510(k) for a shoulder prosthesis.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Equivalence) | Reported Device Performance |
|---|---|
| Material Equivalence: Made of same materials as predicate devices. | The ARROW® anatomical shoulder system and the selected predicate devices are made out of the same materials (titanium alloy for the humeral stem, cobalt chromium alloy for the humeral head, polyethylene for the cemented glenoid). |
| Design Feature Equivalence: Similar design features to predicate devices. | The ARROW® anatomical shoulder system and the selected predicate devices bear design features similarities. |
| Size Range Equivalence: Available in similar ranges of sizes as predicate devices. | The ARROW® anatomical shoulder system and the selected predicate devices are available in similar ranges of sizes. |
| Mechanical Performance: Tested according to recognized standards to ensure appropriate mechanical integrity and function. | The ARROW® anatomical shoulder system was tested according to: - ASTM F1738-05 (Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Forgings for Surgical Implants) - ASTM F1829-98 (Standard Specification for Universal Metallic Extension Fixation Systems) - ASTM F2028-05 (Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants) for the glenoid components. |
| Performance Conclusion: Performance determined to be substantially equivalent to predicate devices. | After testing, it was determined that the ARROW® anatomical shoulder system performances were substantially equivalent to those of the selected predicate devices. |
| Risk Mitigation: Risks to health addressed through specified materials, processing, quality, and compliance. | Risks to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of device performance testing for substantial equivalence for a shoulder prosthesis. The testing was mechanical/material specific based on ASTM standards, not a clinical test set with patient data.
- Data Provenance: Not applicable. The "test set" here refers to physical components of the device undergoing mechanical testing, not a dataset of patient information.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on clinical findings, is not established for this type of mechanical testing. The "ground truth" for the mechanical tests would be the accepted parameters defined by the ASTM standards.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no clinical test set requiring adjudication in this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a shoulder prosthesis, and this type of study is typically performed for diagnostic devices (e.g., AI for radiology interpretation).
- Effect Size: Not applicable as no MRMC study was performed.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Standalone Performance Study: Not applicable. This device is a physical shoulder prosthesis, not a software algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: For the mechanical performance "testing," the "ground truth" is defined by the established ASTM (American Society for Testing and Materials) standards (ASTM F1738-05, ASTM F1829-98, and ASTM F2028-05). Compliance with these standards demonstrates acceptable mechanical properties and material performance.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no "training set" in the context of a physical medical device like a shoulder prosthesis. The design and manufacturing processes are developed through engineering and materials science, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As there is no training set, there is no ground truth established in this manner. The "ground truth" for the device's design and material selection would be established through established engineering principles, biomechanical understanding, and regulatory requirements, which are inherent to the development of such an implant.
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Fournitures Hospitalières industrie
ARROW® anatomical shoulder system Traditional 510(k) Premarket Notification
K093599
alletting the state the minister in the same in a man and in a
NOV 2 4 2010
5. 510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance to the requirements of SDMA 1990 and 21 CFR 807.92.
Date prepared: September 2nd 2010
The assigned 510(k) number is: K0903599
| 5-1. Applicant: | Fournitures Hospitalières industrie |
|---|---|
| 6 Rue Nobel, Z.I. de Kernévez29000 QUIMPER - FRANCETel: (+33) 2.98.55.68.95Fax: (+33) 2.98.53.42.13 |
5-2. Company Contact: Franck HUNT, General Manager Tel: (+33) 2.98.55.68.95
5-3. Product :
ン...
、
| Trade name: | ARROW® anatomical shoulder system | |
|---|---|---|
| Common name: | Shoulder prosthesis | |
| Classification: | The ARROW® anatomical shoulder system components are included in the following classifications:- Shoulder joint metal/ polymer semi-constrained cemented prosthesisProduct code: KWSRegulation: 21 CFR 888.3660Class: II- Shoulder joint metal/polymer non-constrained cemented prosthesisProduct code: KWTRegulation: 21 CFR 888.3650Class: II- Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesisProduct code: HSDRegulation: 21 CFR 888.3690Class: II |
5-4. Predicate/ Legally Marketed Devices :
Information on devices to which substantial equivalence is claimed:
| Manufacturer: | DePuy Orthopaedics, Inc |
|---|---|
| Device Trade Name: | GlobalTM Advantage Shoulder |
| 510 (K): | K984541/K992065 |
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Fournitures Hospitalières industrie
Manufacturer: Device Trade Name: 210 (K):
Exactech, Inc. Exactech Equinoxe® Shoulder System K042021/ K061454
5-5. Device Description:
The ARROW® anatomical shoulder system is a modular shoulder prosthesis, composed of the following elements:
- humeral stems,
- humeral heads (centred or off-centred),
- cemented glenoids.
The ARROW® anatomical shoulder system is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.
5-6. Indications for Use/ Intended Use:
As stated in the Indications for Use section and on the product related labeling (instructions for use and commercial documents):
> Simple humeral prosthesis:
- Four-part proximal humeral fracture, or dislocation fracture. .
- Humeral head necrosis without injury to the glenoid cavity. -
- Extensive humeral head cartilage damage without injury to the glenoid cavity -
- Centered osteoarthritis with a glenoid cavity not allowing implantation of a . glenoid implant.
- Rheumatoid polyarthritis with thin rotator cuff. -
- Off-centered osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.
-
Total anatomical prosthesis (cemented glenoid implant with 4 pegs)
-
- Centered glenohumeral osteoarthritis with functional rotator cuff l
- Rheumatoid polyarthritis with functional rotator cuff -
- Fracture sequela, functional rotator cuff with glenoid injury. -
5-7. Comparison of Technological Characteristics:
The ARROW® anatomical shoulder system and the selected predicate devices have the same intended use and substantial similar indications for use and share the following similarities:
- they are made out of the same materials (titanium alloy for the humeral stem, cobalt chromium alloy for the humeral head, polyethylene for the cemented glenoid),
- they are available in similar ranges of sizes, -
- they bear design features similarities.
5-8. Performances:
The ARROW® anatomical shoulder system was tested according to ASTM F1738-05, ASTM F1829-98 and ASTM F2028-05 for the glenoid components.
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After the testing was completed, it was determined that the ARROW® anatomical shoulder system performances were substantially equivalent to those of the selected predicate devices.
Risks to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations.
5-9. Substantial Equivalence:
The substantial equivalence of our products when compared to the selected predicate devices has been established following manufacturers' commercial documents, 510(k) submission's information available on FDA's website as well as conformance to standards in force.
The analysis of these technical data allows us to submit the ARROW® anatomical shoulder system as being substantially equivalent to the already cleared predicate devices selected to a draw a comparison.
All data on predicate devices which has been used to establish substantial equivatence is available in appendix 8.
5-10. Conclusion:
Following the examination of all the above mentioned information, we believe that the ARROW® anatomical shoulder system is substantially equivalent to the selected predicate devices in terms of design, ranges of sizes, materials, intended use, performances, safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
Fournitures Hospitalieres Industrie % Ms. Patricia Donnard Regulatory Affairs ZI de Kernevez 6 rue Nobel 29000 QUIMPER France
NOV 2 4 2010
Re: K093599
Trade/Device Name: ARROW® anatomical shoulder system Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, KWT, HSD Dated: October 25, 2010 Received: October 27, 2010
Dear Ms. Donnard:
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 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 (reporting of medical
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Page 2 - Ms. Patricia Donnard
device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
lttp://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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Milham
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use
510(k) Number (if known): K093599
. NOV 2 4 2010
Device Name: ARROW® anatomical shoulder system This device is composed of the following elements: - humeral stems, - humeral heads (centred or off-centred), - cemented glenoids. ARROW® Indications for Use: The anatomical shoulder system, depending on the components used, is designed for:
Simple humeral prosthesis:
- Fracture dislocation or complex four part fracture of the proximal humerus -
- Humeral head necrosis without injury to the glenoid cavity. -
- Extensive humeral head cartilage damage without injury to the glenoid cavity -
- Centered osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
- Rheumatoid polyarthritis with thin rotator cuff. -
- Off-centered osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.
Total anatomical prosthesis (cemented glenoid implant with 4 pegs)
AND/OR
- Centered glenohumeral osteoarthritis with functional rotator cuff -
- -Rheumatoid polyarthritis with functional rotator cuff
- . Fracture sequela, functional rotator cuff with glenoid injury.
Prescription Use: Yes (Part 21 CFR 801 Subpart D) Over the counter Use: No (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page of
Mark H. Milliken
(Division Sign-Oft) (Division Sign-Off)
Division of Surgical, Orthopedic,
Division of Surgices Division of Surg.
and Restorative Devices
510(k) Number .
§ 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.”