(266 days)
No
The description focuses on patient-specific guides created from 3D planning based on CT scans, without mentioning AI or ML in the process of generating the guides or the planning.
No
The device is a surgical guide used for accurate placement of shoulder implants, not a therapeutic device that treats or cures a disease or condition.
No
Explanation: The device, MyShoulder Patient-Matched Guides, is described as surgical instruments intended to guide the placement of shoulder implants during surgery based on a 3D planning from a patient's CT scan. It functions as a placement guide for surgical procedures, not as a tool to diagnose a condition or disease.
No
The device description explicitly states that the MyShoulder™ Placement guides are manufactured from medical grade nylon and are physical surgical instruments, not software. While software is used in the planning process, the final device is a physical guide.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the MyShoulder guides are "surgical instruments" used to "guide the glenoidal reaming" and "define the level and orientation of the humeral head resection cut." This describes a device used during a surgical procedure to aid in the placement of implants, not a device used to perform tests on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description reinforces that these are "patient specific surgical instruments" and "anatomical guides for a single patient anatomy." They are used in conjunction with surgical implants.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide diagnostic information about a patient's health status.
- Input and Output: The input is a CT scan (imaging data), and the output is a physical surgical guide. This is consistent with surgical planning and guidance tools, not IVDs.
IVDs are defined as devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures. This device does not fit this definition.
N/A
Intended Use / Indications for Use
The MyShoulder guides are intended to be used as guides specifically designed for the anatomy of a single patient. The humeral guide is used to define the level and orientation of the humeral head resection cut. The glenoidal guide is used to position and orient the K-wire that will subsequently guide the glenoidal reaming.
Both anatomical and reverse total joint configurations are acceptable.
Both humeral and glenoid guides are suitable for a delto-pectoral approach only.
MyShoulder Patient-Matched Guides are intended for use with Medacta Shoulder System and its cleared indications for use.
MyShoulder Patient-Matched Guides are intended for single use only.
Product codes
PHX, KWS, HSD, MBF
Device Description
The MyShoulder™ Placement Guides are patient specific surgical instruments that allow for guided shoulder implants placement of both Medacta Shoulder Reverse System (K170452) and Medacta Anatomic Shoulder Prosthesis (K170910) and the additional products cleared under K181826 (Glenoid Polyaxial Non-locking screws), K180089 (Short Humeral Stem) and K171058 (Threaded Glenoid Baseplate).
The MyShoulder™ Placement guides uses the patient's CT Scan to perform a 3D planning of the glenohumeral joint replacement surgery. Then, following this planning the humeral and glenoidal guides are created. The MyShoulder™ Placement guides are anatomical guides for a single patient anatomy.
The MyShoulder™ Placement guides subject of this submission are comprised of the following products:
-
- MyShoulder™ humeral guide: it will allow to perform an accurate humeral resection
-
- MyShoulder™ glenoidal guide: it will provide a precise alignment reference that will guide the glenoidal reaming and final implant positioning.
The MyShoulder™ Placement guides are manufactured from medical grade nylon for sintering (Polyamide PA 12) which is identical to Medacta reference device MySpine Pedicle Screw Placement Guides (132788). The MyShoulder™ Placement guides are single use, external communicating devices with limited (
§ 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.”
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 13, 2019
Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street MEMPHIS TN 38118
Re: K190738
Trade/Device Name: MyShoulder Placement Guides Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, KWS, HSD, MBF Dated: November 13, 2019 Received: November 14, 2019
Dear Chris Lussier:
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.
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
1
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 (OS) 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 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,
for
Michael C. Owens Acting 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)
K190738
Device Name MyShoulder™ Placement Guides
Indications for Use (Describe)
The MyShoulder guides are intended to be used as guides specifically designed for the anatomy of a single patient. The humeral guide is used to define the level and orientation of the humeral head resection cut. The glenoidal guide is used to position and orient the K-wire that will subsequently guide the glenoidal reaming.
Both anatomical and reverse total joint configurations are acceptable.
Both humeral and glenoid guides are suitable for a delto-pectoral approach only.
MyShoulder Patient-Matched Guides are intended for use with Medacta Shoulder System and its cleared indications for use.
MyShoulder Patient-Matched Guides are intended for single use only.
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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2.0 510(k) Summary
K190738
I. Submitter
Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Contact Person: Stefano Baj, Regulatory and Compliance Director, Medacta International SA Date Prepared: Mar 21, 2019 Date Revised: November 13, 2019
II. Device
| Device Proprietary Name: | MyShoulder™ Placement Guides |
|---|---|
| Common or Usual Name: | Shoulder Prosthesis System |
| Classification Name: | Shoulder joint metal/polymer semi-constrained cemented prosthesis |
| Primary Product Code: | PHX |
| Secondary Product Code: | KWS, HSD, MBF |
| Regulation Number: | 21 CFR 888.3660, 21 CFR 888.3690, and 21 CFR 888.3670 |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is therefore claimed to the following devices:
-
Primary Predicate: BLUEPRINT Patient Specific Instrumentation (K143374), Wright-Tornier
- Reference Device: A
- Anatomic Shoulder Prosthesis (K170910), Medacta International SA
- Shoulder Reverse System (K170452), Medacta International SA ●
- MySpine Pedicle Screw Placement Guides (132788), Medacta International SA ●
IV. Device Description
The MyShoulder" Placement Guides are patient specific surgical instruments that allow for guided shoulder implants placement of both Medacta Shoulder Reverse System (K170452) and Medacta Anatomic Shoulder Prosthesis (K170910) and the additional products cleared under K181826 (Glenoid Polyaxial Non-locking screws), K180089 (Short Humeral Stem) and K171058 (Threaded Glenoid Baseplate).
4
The MyShoulder™ Placement guides uses the patient's CT Scan to perform a 3D planning of the glenohumeral joint replacement surgery. Then, following this planning the humeral and glenoidal guides are created. The MyShoulder™ Placement guides are anatomical guides for a single patient anatomy.
The MyShoulder™ Placement guides subject of this submission are comprised of the following products:
-
- MyShoulder™ humeral guide: it will allow to perform an accurate humeral resection
-
- MyShoulder™ glenoidal guide: it will provide a precise alignment reference that will guide the glenoidal reaming and final implant positioning.
The MyShoulder™ Placement guides are manufactured from medical grade nylon for sintering (Polyamide PA 12) which is identical to Medacta reference device MySpine Pedicle Screw Placement Guides (132788). The MyShoulder™ Placement guides are single use, external communicating devices with limited (