(351 days)
K031454, 510(k) exempt (888.4540)
No
The summary describes a software and hardware system for surgical guidance based on anatomical landmarks identified on MRI scans, but it does not mention or imply the use of AI or ML for image processing, planning, or any other function.
No.
The device is a surgical instrument intended to assist in the orientation of acetabular cup components, not directly treat a disease or condition.
No
The device is a surgical instrument intended to assist in the orientation of acetabular cup components intra-operatively, not to diagnose a condition.
No
The device description explicitly states that the system consists of both a software component (Signature™ Planner) and a hardware component (Signature™ guides).
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 system is a "surgical instrument to assist in the orientation of acetabular cup components intra-operatively." This describes a device used during a surgical procedure to guide the placement of an implant.
- Device Description: The description reinforces this by detailing software for planning and hardware (guides) for use in surgery.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
- Input: While it uses MRI imaging scans, these are used for planning the surgical procedure, not for analyzing biological markers or characteristics within the body.
- Anatomical Site: The focus is on the pelvis as the anatomical site for the surgical intervention, not for obtaining a specimen for analysis.
In summary, the Signature™ Personalized Patient Care System – Acetabular Guide System is a surgical planning and guidance system used in vivo (within the body) during surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Signature™ Personalized Patient Care System – Acetabular Guide System is intended to be used as a surgical instrument to assist in the orientation of acetabular cup components intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative MRI imaging scans.
The Signature™ Personalized Patient Care System - Acetabular Guide System can be used with all Biomet 510(k) cleared, legally marketed, primary acetabular systems and their respective components.
The Signature™ guides are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
LPH, LZO, KWZ, JDI, KWY, MAY, MEH
Device Description
The Acetabular Guide System consists of a software component, Signature™ Planner and a hardware component, Signature™ guides and is designed to assist the surgeon in the orientation of an acetabular cup.
The Signature™ Personalized Patient Care System - Acetabular Guide System can be used with the following Biomet acetabular systems and their respective compatible components: Bio-Clad™ All-Poly Cup (K810120 and K926107), Ranawat/Burstein™ All-Poly Cup (preamendment), RX-90™ Low Profile Shell (K920639 and K042989), Full Hemisphere Shell (K920640), Mallory/Head™ Shells (K861114, K921181, and K030055), Quadrant Sparing Shells (K920640 and K050124), Ranawat/Burstein™ Shells (K911685, K921277, and K050124), Regenerex™ Porous Titanium Shells (K052996), Regenerex™ Ringloc+ Shell System (K070369), Ringloc+ Acetabular System (K070369), Tri-Spike Pegged Shells (K970501 and K030055), Tri-Polar Shell (K991990), Universal Shells (K861433, K921301, and K030055), Vision™ Shells (K954417 and K030055), Freedom™ Constrained All-Poly Cups (K030047), M2a-Magnum™ with E1™ Active Articulation (K101336), and M2a-Magnum™ with ArComXL™ Active Articulation (K110555).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI imaging data
Anatomical Site
Pelvis, acetabulum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified surgeon
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)
Accuracy performance testing and guide dimensional stability testing was performed to determine substantial equivalence. Testing verified that the accuracy and performance of the system is adequate to perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K031454, 510(k) exempt (888.4540)
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
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip 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 femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular 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.
0
JUN 1 5 2012
510(k) Summary
Submitter information
| Company name | Materialise N.V. |
|---|---|
| Establishment registration number | 3003998208 |
| Street Address | Technologielaan 15 |
| City | Leuven |
| Postal code | 3001 |
| Country | Belgium |
| Phone number | +32 16 39 62 80 |
| Fax number | +32 16 39 66 06 |
| Contact name | Alexandra Razzhivina |
| Contact title | Regulatory Officer |
| Contact e-mail address | alexandra.razzhivina@materialise.be |
Submission date
The date of the Traditional 510(k) submission is 28th June, 2011.
Submission information
| Trade Name | Signature™ Planner
Signature™ guides |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Hip prosthesis |
| Classification Name | - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented
- Prosthesis, Hip, Constrained, Cemented or Uncemented, Metal/Polymer
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Prosthesis, Hip, Hemi-Femoral, Metal/Polymer, Cemented or Uncemented
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous Cemented, Osteophilic Finish
- Prosthesis, Hip, Semi-constrained, Uncemented, Metal/Polymer, Non-Porous, Calcium-Phosphate |
| Primary product codes | LPH |
| Secondary product codes | LZO, KWZ, JDI, KWY, MAY, MEH |
Predicate devices
| Predicate Device | |
|---|---|
| Trade or proprietary or model name | SurgiCase |
| 510(k) number | K073449 |
| Decision date | 04/16/2008 |
| Product code | LLZ |
| Manufacturer | Materialise N.V. |
1
| Predicate Device | |
|---|---|
| Trade or proprietary or model name | Signature™ Personalized Patient Care System |
| 510(k) number | K102795 |
| Decision date | 02/02/2011 |
| Product code | JWH/OIY, MBH, OOG |
| Manufacturer | Materialise N.V. |
| Predicate Device | |
|---|---|
| Trade or proprietary or model name | Acumen Surgical Navigation System |
| 510(k) number | K031454 |
| Decision date | 07/08/2004 |
| Product code | HAW |
| Manufacturer | Biomet Manufacturing |
| Predicate Device | |
| Trade or proprietary or model name | Instrument |
| 510(k) number | 510(k) exempt (888.4540) |
| Decision date | NA |
| Product code | KIL |
| Manufacturer | Biomet Manufacturing |
Device Information
Description of the device
The Acetabular Guide System consists of a software component, Signature™ Planner and a hardware component, Signature™ guides and is designed to assist the surgeon in the orientation of an acetabular cup.
The Signature™ Personalized Patient Care System - Acetabular Guide System can be used with the following Biomet acetabular systems and their respective compatible components: Bio-Clad™ All-Poly Cup (K810120 and K926107), Ranawat/Burstein™ All-Poly Cup (preamendment), RX-90™ Low Profile Shell (K920639 and K042989), Full Hemisphere Shell (K920640), Mallory/Head™ Shells (K861114, K921181, and K030055), Quadrant Sparing Shells (K920640 and K050124), Ranawat/Burstein™ Shells (K911685, K921277, and K050124), Regenerex™ Porous Titanium Shells (K052996), Regenerex™ Ringloc+ Shell System (K070369), Ringloc+ Acetabular System (K070369), Tri-Spike Pegged Shells (K970501 and K030055), Tri-Polar Shell (K991990), Universal Shells (K861433, K921301, and K030055), Vision™ Shells (K954417 and K030055), Freedom™ Constrained All-Poly Cups (K030047), M2a-Magnum™ with E1™ Active Articulation (K101336), and M2a-Magnum™ with ArComXL™ Active Articulation (K110555).
Functioning of the device
The Acetabular Guide System generates a pre-surgical plan based on MRI imaging data using the Signature™ Planner (software component). The software is then used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan. Next,
2
Signature™ guides are designed and manufactured based on the approved pre-surgical plan. Signature™ guides are patient specific templates that transfer the pre-operatively determined pin locations and the planned acetabular cup orientation to the patient intraoperatively. The first surgical guide (Primary Acetabular Guide) is used to place two pins near the acetabular rim. A second surgical guide (Secondary Acetabular Guide) is then assembled to these pins and is used to recreate the pre-operatively determined acetabular cup orientation by positioning an alignment pin parallel to the planned cup insertion location. The surgeon may then place the acetabular cup implant in the pre-operatively determined location by aligning the inserter handle with the alignment pin held by the secondary acetabular guide. The alignment pin adaptor, an optional accessory, attaches to the cup inserter handle and interfaces with the alignment pin using a slot and a series of magnets. This orients the cup inserter handle parallel to the alignment pin during insertion of the acetabular cup.
Intended use
The Signature™ Personalized Patient Care System - Acetabular Guide System is intended to be used as a surgical instrument to assist in the orientation of acetabular cup components intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative MRI imaging scans.
The Signature™ Personalized Patient Care System - Acetabular Guide System can be used with all Biomet 510(k) cleared, legally marketed, primary acetabular systems and their respective components.
. The Signature™ guides are intended for single use only.
Summary of technological characteristics
Device comparison showed that the proposed device is substantially equivalent in intended use, materials and performance characteristics to the predicate devices.
Performance data
Non-clinical tests
Accuracy performance testing and guide dimensional stability testing was performed to determine substantial equivalence. Testing verified that the accuracy and performance of the system is adequate to perform as intended.
Clinical data
Not applicable.
3
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 depiction of an eagle or bird with outstretched wings. The bird is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
JUN 1 5 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Materialise N.V. Yo Ms. Alaxandra Razzhivina 15 Technologielaan Leuven, Belgium 3001
Re: K111863
Trade/Device Name: Signature Planner, Signature Guides Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO, KWZ, JDI, KWY, MAY, MEH Dated: June 05, 2012 Received: June 07, 2012
Dear Ms. Razzhivina:
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. 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 r house of as note a determination that your device complies with other requirements of the Act
4
Page 2 – Ms. Alaxandra Razzhivina
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); 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
http://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. Milliken
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K111863
Signature™ Personalized Patient Care System - Acetabular Guide System Device Name: (Signature™ Guides, Signature™ Planner)
Indications for Use:
The Signature™ Personalized Patient Care System – Acetabular Guide System is intended to be used as a surgical instrument to assist in the orientation of acetabular cup components intra-operatively using anatomical landmarks of the pelvis that are clearly identifiable on preoperative MRI imaging scans.
The Signature™ Personalized Patient Care System - Acetabular Guide System can be used with all Biomet 510(k) cleared, legally marketed, primary acetabular systems and their respective components.
The Signature™ guides are intended for single use only.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
s
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number