(123 days)
No
The summary describes software for pre-surgical planning and patient-specific instrumentation design based on CT scans, but it does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device components (software and 3D positioners) are designed to assist in surgical planning and intraoperative positioning, not to diagnose, treat, or prevent a disease or condition directly.
No
The text explicitly states: "Smart SPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes."
No
The device description explicitly states the system consists of both the Smart SPACE Shoulder Planner software and 3D Positioners, which are physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This typically involves tests performed on blood, urine, tissue, etc., outside of the body.
- Device Intended Use: The Smart SPACE Shoulder System is intended for pre-surgical planning and intraoperative positioning during shoulder arthroplasty procedures. It uses patient-specific CT scans to create a surgical plan and guide the placement of components.
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "Smart SPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes."
Therefore, the device's function and stated purpose clearly fall outside the scope of In Vitro Diagnostics. It is a surgical planning and guidance system, not a diagnostic test performed on biological specimens.
N/A
Intended Use / Indications for Use
Smart SPACE Shoulder 3D Positioners
Smart SPACE Shoulder System instrumentation consists of patient-specific 3D positioners. They have been specially designed to assist in the intraoperative positioning of shoulder components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.
Smart SPACE Shoulder Planner software
Smart SPACE Shoulder Planner software is a medical device for surgeons composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.
Smart SPACE Shoulder Planner software runs on standard personal and business computers running Microsoft Windows operating system.
The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with the Smart SPACE Shoulder Planner software.
Smart SPACE Shoulder Planner software allows the surgeon to visualize, measure, reconstruct, annotate and edit anatomic data.
It allows the surgeon to design shoulder patient-specific instrumentation based on the pre-surgical plan. The software leads to the generation of a surgical report along with a 3D file of the shoulder patient-specific instrumentation.
Smart SPACE Shoulder Planner software does not include any system to manufacture the shoulder patient-specific instrumentation.
Smart SPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes.
Product codes
OHE, KWS, MBF
Device Description
The Smart SPACE Shoulder System consists of the Smart SPACE Shoulder Planner software and 3D Positioners which assist the user in planning reverse and anatomic total shoulder arthroplasty and gives the user the ability to translate the surgical plan intraoperatively using 3D positioners for glenoid K-wire placement and humeral head resection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan (Computed Tomography)
Anatomical Site
Shoulder
Indicated Patient Age Range
adult patients only
Intended User / Care Setting
surgeons
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)
- Sterilization & Shelf-life Testing: Testing was performed to validate the end-user sterilization protocol of the subject device.
- Biocompatibility Testing: Biocompatibility testing per ISO 10993-1 was conducted to ensure the biocompatibility of the materials used in the 3D positioners.
- Electrical safety and electromagnetic compatibility (EMC): Not applicable as there is not an energy source beyond that of the computer used with the planning software.
- Software Verification and Validation Testing: Conducted in accordance with IEC 62304 and FDA guidance documents.
- Mechanical and Acoustic Testing: Not applicable as the device is intended to be used as a temporary guide during a surgical procedure without critical mechanical performance testing requirements.
- Animal Study: Not required.
- Clinical Studies: Cadaveric studies demonstrated that the subject device translated the humeral head resection in a more accurate and precise manner compared to traditional instrumentation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
More accurate and precise manner compared to traditional instrumentation.
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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
§ 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). 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.
TechMah Medical LLC Mary Vater Regulatory Consultant Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, Vermont 05738 USA
December 28, 2020
Re: K202454
Trade/Device Name: Smart SPACE Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: OHE, KWS, MBF Dated: December 1, 2020 Received: December 1, 2020
Dear Mary Vater:
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 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 (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-reporting-mdr-howreport-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorywebsite the DICE assistance/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 Owens Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202454
Device Name Smart SPACE Shoulder System
Indications for Use (Describe) Smart SPACE Shoulder 3D Positioners
Smart SPACE Shoulder System instrumentation consists of patient-specific 3D positioners. They have been specially designed to assist in the intraoperative positioning of shoulder components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.
Smart SPACE Shoulder Planner software
Smart SPACE Shoulder Planner software is a medical device for surgeons composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.
Smart SPACE Shoulder Planner software runs on standard personal and business computers running Microsoft Windows operating system.
The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with the Smart SPACE Shoulder Planner software.
Smart SPACE Shoulder Planner software allows the surgeon to visualize, measure, reconstruct, annotate and edit anatomic data.
It allows the surgeon to design shoulder patient-specific instrumentation based on the pre-surgical plan. The software leads to the generation of a surgical report along with a 3D file of the shoulder patient-specific instrumentation.
Smart SPACE Shoulder Planner software does not include any system to manufacture the shoulder patient-specific instrumentation.
Smart SPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes.
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
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
| I. | SUBMITTER
TechMah Medical LLC
2099 Thunderhead Rd., Suite 302
Knoxville, TN 37922
Tel: +1.877.725.6920 ext. 104 | |
|------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Primary Contact Person:
Contact Person:
Date Prepared: | Mary Vater, 510(k) Consultant; email: mary@fdaecopy.com
Mohamed R. Mahfouz, Ph.D.
August 25, 2020 |
| II. | DEVICE
Name of Device:
Classification Name: | Smart SPACE Shoulder System
Shoulder Arthroplasty Implantation System
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Prosthesis,
Shoulder, Semi-Constrained, Metal/Polymer Uncemented |
| | Regulation:
Regulatory Class:
Product Classification Code: | 21 CFR §888.3660 and 21 CFR §888.3670
Class II
QHE, KWS and MBF (The device is a planning system and
surgical guides, primary code QHE, intended to be used with
devices in product codes KWS and MBF) |
| III. | PREDICATE DEVICE
Predicate Manufacturer:
Predicate Trade Name: | TechMah Medical LLC
SmartSPACE Shoulder System |
Predicate 510(k): K191247
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The Smart SPACE Shoulder System consists of the Smart SPACE Shoulder Planner software and 3D Positioners which assist the user in planning reverse and anatomic total shoulder arthroplasty and gives the user the ability to translate the surgical plan intraoperatively using 3D positioners for glenoid K-wire placement and humeral head resection.
V. INDICATIONS FOR USE
Smart SPACE Shoulder 3D Positioners
Smart SPACE Shoulder system instrumentation consists of patient-specific 3D positioners. They have been specially designed to assist in the intraoperative positioning of shoulder components used with total anatomic or reverse shoulder arthroplasty procedures using anatomic landmarks that are identifiable on patient-specific preoperative CT scans.
Smart SPACE Shoulder Planner software
4
Smart SPACE Shoulder Planner software is a medical device for surgeons composed of one software component. It is intended to be used as a pre-surgical planner for shoulder orthopedic surgery.
Smart SPACE Shoulder Planner software runs on standard personal and business computers running Microsoft Windows operating system.
The software supports DICOM standard to import the CT scan (Computed Tomography) images of the patient. Only CT scan modality can be loaded with the Smart SPACE Shoulder Planner software.
Smart SPACE Shoulder Planner software allows the surgeon to visualize, measure, reconstruct, annotate and edit anatomic data.
It allows the surgeon to design shoulder patient-specific instrumentation based on the presurgical plan.
The software leads to the generation of a surgical report along with a 3D file of the shoulder patient-specific instrumentation.
Smart SPACE Shoulder Planner software does not include any system to manufacture the shoulder patient-specific instrumentation.
Smart SPACE Shoulder Planner software is to be used for adult patients only and should not be used for diagnostic purposes.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:
- । Indications for Use - The predicate and subject device have equivalent indications for use.
- -Materials – The predicate and subject device have the same patient contacting materials of PA 2200.
- -Design - The predicate and subject device use the same software technology for the surgical planning and the final design of the 3D positioners.
- -Energy Source – The predicate and subject devices' software runs on computers, the guides themselves do not have an energy source.
- -Other Design Features - The subject device builds on already approved Smart SPACE shoulder system (K191247 / Predicate). Novel features in this device compared to predicate is the humerus 3D positioner which is a patient specific device that aids the surgeon in the resection of humeral head.
- । Performance Testing – The subject and predicate device were primarily validated using non-clinical studies performed on cadaveric specimens. The primary validation method is the same and demonstrate compliance with the same recognized standards, demonstrating equivalence.
PERFORMANCE DATA VII.
The following performance data were provided in support of the substantial equivalence determination.
Sterilization & Shelf-life Testing
Testing was performed to validate the end-user sterilization protocol of the subject device.
Biocompatibility Testing
Biocompatibility testing per ISO 10993-1 was conducted to ensure the biocompatibility of the materials used in the 3D positioners.
Electrical safety and electromagnetic compatibility (EMC)
5
Electrical Safety and Electromagnetic Compatibility testing is not applicable for these devices as there is not an energy source beyond that of the computer used with the planning software, which does not pose significant risk to users or patients.
Software Verification and Validation Testing
Software Verification and Validation Testing was conducted in accordance with the requirements of IEC 62304 and the following FDA guidance documents: General Principles of Software Validation, Off-The-Shelf Software Used in Medical Devices, Cybersecurity for Networked Medical Devices Containing Offthe-Shelf Software, Postmarket Management of Cybersecurity in Medical Devices, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Mechanical and Acoustic Testing
Mechanical and Acoustic Testing was not applicable for this submission because the device is intended to be used as a temporary guide during a surgical procedure without critical mechanical performance testing requirements.
Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Clinical Studies
Clinitod SosiangSPACIDShoplitedSopsCentrationalsFormationStandithondsswalithsoderformed on cadaveric specimens.
Bellege:Recogeners with the executed with the executed humeral head cut using the Smart SPACE Humerus 3D Positioner.
Testing has successfully demonstrated that the subject device performs as well as existing traditional instrumentation currently used for executing the humeral head resection. The subject device translated the humeral head resection in a more accurate and precise manner compared to traditional instrumentation.
VIII. CONCLUSIONS
The Smart SPACE Shoulder System (Subject Device System) described in this section has an equivalent intended use and the same fundamental scientific technology as the cleared SmartSPACE Shoulder System (K191247). Based on the performance data presented for the subject device and predicate device, TechMah Medical concludes that the subject device is substantially equivalent to the predicate device.