(143 days)
K11631
No
The submission focuses solely on adding an "MR-Conditional" statement to existing devices. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is an anchor used for fixation of ligaments and tendons during surgical repair, not for therapy itself, according to the "Intended Use / Indications for Use" section. The 510(k) submission is solely to add an "MR-Conditional" statement.
No
The device description and intended use clearly state that it is an anchor device used for surgical repairs and reconstruction in various anatomical sites. The 510(k) submission is solely to add an "MR-Conditional" statement, which indicates its compatibility with MRI, not that it performs diagnostic functions itself.
No
The device described is a physical implant (GII™ Anchor) and the 510(k) is for adding an MR-Conditional statement to its labeling, not for a software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the device's function in surgical procedures for repairing and reconstructing various anatomical structures (shoulder, ankle, foot, wrist, hand, elbow, knee, pubic bone). This is a therapeutic and surgical application, not a diagnostic one.
- Device Description: The description focuses on the device being a surgical anchor and the proposed change being the addition of an "MR-Conditional" statement. This further reinforces its nature as a surgical implant.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide information for diagnosis.
- Performance Studies: The performance studies described relate to the device's compatibility with MRI, which is relevant for a surgical implant that might be present during an MRI scan, not for a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
SHOULDER: Acromio-clavicular; Bankart repair; Biceps tenodesis; Capsule shift/capsulolabral reconstruction; Deltoid repair; Rotator cuff repair; SLAP lesion repair. ANKLE: Achilles tendon repair/reconstruction; Lateral instability; Medial instability; Midfoot reconstructions. FOOT: Hallux valgus reconstruction. WRIST: Scapholunate ligament reconstruction. HAND: Ulnar or lateral collateral ligament reconstruction. ELBOW: Biceps tendon reattachment; Tennis elbow repair. KNEE: Extra capsular reconstruction, ITB tenodesis; Lateral ligament; Patellar ligament and tendon avulsion repairs; Posterior oblique ligament or joint capsule to tibia; Joint capsule closure to anterior proximal tibia; Medial collateral ligament. BNS: Fixation in pubic bone for bladder neck suspension using USP #2 Class I nonabsorbable synthetic suture (e.g. polypropylene). A minimum of 2 Anchors should be used in this procedure.
Product codes
MBI, JDR
Device Description
The only proposition of this 510(k) submission is to add a "MR-Conditional" statement and symbol to all applicable product package-insert and labels of GII™ Anchor devices. Technological characteristics including indications, product design, material, and packaging are the same as the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Ankle, Foot, Wrist, Hand, Elbow, Knee, Pubic bone
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
MRI Testing using a scanner operating with a static magnetic field was performed on the DePuy Mitek metal implant devices. The test performed, included magnetic field interaction, MRI-related heating, and the presence of artifacts at 3.0 Tesla. Results of "Evaluation of Magnetic Field Interactions, Heating, and Artifacts" have demonstrated that the currently marketed DePuy Mitek GII™ Anchors are "MR-conditional".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K11631
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the DePuy Mitek Inc. logo with the tagline "never stop moving." The logo is black and white and features the DePuy name in a stylized font. Below the name is the text "Mitek Inc." and ".johnson&johnson company" in a smaller font. The tagline is in a cursive font and is located to the right of the logo.
GII™ ANCHOR PRODUCT: SUBMISSION DATE: AUGUST 22°0, 2011 SUBMISSION TYPE: TRADITIONAL
JAN 1 3 2012
ATTACHMENT 1
5 10(k) SUMMARY - DePuy Mitek GII™ ANCHOR
SUBMITTER'S NAME AND ADDRESS
DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767
CONTACT PERSON
Deep Pal Senior Regulatory Affairs Specialist DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767
| TELEPHONE | 508-828-3339 |
|---|---|
| FACSIMILE | 508-977-6911 |
| dpal3@its.jnj.com | |
| DATE PREPARED | August 22nd, 2011 |
NAME OF MEDICAL DEVICE
| with the state of the country and control control of the contrôlection of the contrôlean con-
| COMMON NAME | |
|---|---|
| Bone Anchors, Screws |
TRADE NAME/PROPRIETARY NAME
- GII™ Anchor .
SUBSTANTIAL EQUIVALENCE
There are no changes being made to the indications, product designs, material, packaging, and to the manufacturing processes. The only proposition of this 510(k) submission is to add a generic "MR-Conditional" statement and symbol to the product package insert and labels.
- GI™ Anchor . K915888
- Various Metal Implants K11631 .
DEVICE CLASSIFICATION
| • | GII™ Anchor - K915889 | |
|---|---|---|
| o | Device Classification: | II |
| o | Device Classification Name: | Fastener, Fixation, Nondegradable, Soft tissue |
| Staple, Fixation, Bone | ||
| o | Regulation Number: | 888.3040-Smooth or threaded metallic bone fixation fastener |
| 888.3030-Single/multiple component metallic bone fixation | ||
| appliances and accessories | ||
| o | Classification Product Code: | MBI, JDR |
1
Image /page/1/Picture/1 description: The image shows the DePuy Synthes logo. The logo includes the text "DePuy Mitek Inc. a Johnson-Johnson company" and the tagline "never stop moving". The logo is black and white and is positioned in the upper left corner of the image.
GII™ ANCHOR PRODUCT: SUBMISSION DATE: AUGUST 2200, 2011 SUBMISSION TYPE: TRADITIONAL
ATTACHMENT 1
1 : 1 / 1 /
Continues ...
5 I 0(k) SUMMARY - DePuy Mitek MRI STATEMENT FOR METAL IMPLANTS
INDICATIONS FOR USE
GII Anchors SHOULDER: Acromio-clavicular; Bankart repair; Biceps tenodesis; Capsule shift/capsulolabral reconstruction; Deltoid repair; Rotator cuff repair; SLAP lesion repair. ANKLE: Achilles tendon repair/reconstruction; Lateral instability; Medial instability; Midfoot reconstructions.
FOOT: Hallux valgus reconstruction.
WRIST: Scapholunate ligament reconstruction.
HAND: Ulnar or lateral collateral ligament reconstruction.
ELBOW: Biceps tendon reattachment; Tennis elbow repair.
KNEE: Extra capsular reconstruction, ITB tenodesis; Lateral ligament; Patellar ligament and tendon avulsion repairs; Posterior oblique ligament or joint capsule to tibia; Joint capsule closure to anterior proximal tibia; Medial collateral ligament.
BNS: Fixation in pubic bone for bladder neck suspension using USP #2 Class I nonabsorbable synthetic suture (e.g. polypropylene). A minimum of 2 Anchors should be used in this procedure.
TECHNOLOGICAL CHARACTERSTICS
The only proposition of this 510(k) submission is to add a "MR-Conditional" statement and symbol to all applicable product package-insert and labels of GII™ Anchor devices. Technological characteristics including indications, product design, material, and packaging are the same as the predicate devices.
NONCLINICAL TESTING
MRI Testing using a scanner operating with a static magnetic field was performed on the DePuy Mitek metal implant devices. The test performed, included magnetic field interaction, MRI-related heating, and the presence of artifacts at 3.0 Tesla.
SAFETY AND PERFORMANCE
Results of "Evaluation of Magnetic Field Interactions, Heating, and Artifacts" have demonstrated that the currently marketed DePuy Mitek GII™ Anchors are "MR-conditional".
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Mr. Deep Pal Regulatory Affairs Specialist II DePuy Mitek Inc., a johnson and johnson company 325 Paramount Drive RAYNHAM MA 02767
JAN 1 3 2012
Re: K112417
Trade/Device Name: GII™ Anchor Regulation Number: 21 CFR§ 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: January 11, 2012 Received: January 12, 2012
Dear Mr. Pal:
We have reviewed your Section 510(k) premarket notification of intent to market the device w oneve and have 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 for about in the 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). and Ocometer for , roo reat 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 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
3
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,
Sincerely yours,
Benjamin K. Twichell
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
never stop moving
| PRODUCT: | GII™ ANCHOR |
|---|---|
| SUBMISSION DATE: | AUGUST 22 ND , 20 |
| SUBMISSION TYPE: | TRADITIONAL |
ATTACHMENT 2
INDICATIONS FOR USE FORMS
| 510(k) Number (if known): | " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "
Controllation of Concession of |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
Device Names: GII™ Anchor
Indications for Use:
SHOULDER: Acromio-clavicular; Bankart repair; Biceps tenodesis; Capsule shift/capsulolabral reconstruction; Deltoid repair; Rotator cuff repair; SLAP lesion repair.
ANKLE: Achilles tendon repair/reconstruction; Lateral instability; Medial instability; Midfoot reconstructions.
FOOT: Hallux valgus reconstruction.
WRIST: Scapholunate ligament reconstruction.
HAND: Ulnar or lateral collateral ligament reconstruction.
ELBOW: Biceps tendon reattachment; Tennis elbow repair.
KNEE: Extra capsular reconstruction, ITB tenodesis; Lateral ligament; Patellar ligament and kNew capsuler repairs; Posterior oblique ligament or joint capsule to tibia; Joint capsule closure to anterior proximal tibia; Medial collateral ligament.
BNS: Fixation in pubic bone for bladder neck suspension using USP #2 Class I nonabsorbable synthetic suture (e.g. polypropylene). A minimum of 2 Anchors should be used in this procedure.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
2011
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Reproductive, Gastro-Renal, and Urological Devices |
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