(31 days)
Not Found
No
The device description and intended use focus on a mechanical suture anchor system, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is an implantable suture anchor system used for soft tissue to bone fixation after injury or disease, which is a restorative rather than therapeutic function.
No
The device, the PANALOK Loop Anchor System, is described as a surgical implant for soft tissue to bone fixation. Its intended uses involve various repairs and reconstructions, which are therapeutic interventions rather than diagnostic procedures. There is no mention of the device being used to identify or analyze diseases or conditions.
No
The device description clearly states it is a "preloaded absorbable disposable suture anchor/inserter assembly," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for soft tissue to bone fixation in various anatomical locations (shoulder, elbow, ankle, foot, knee). This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details a suture anchor/inserter assembly made of absorbable material. This is a physical implant used during surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The mentioned performance studies focus on biocompatibility, which is relevant for implanted devices, not IVDs.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The PANALOK Loop Anchor System does not fit this description.
N/A
Intended Use / Indications for Use
The Panalok Loop Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows: OPEN PROCEDURES - SHOULDER - 1. Bankart repair - 2. SLAP lesion repair - 3. Rotator cuff repair - 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site - 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus - 5. Biceps tenodesis - 6. Acromio-clavicular separation - 7. Deltoid repair ELBOW - 1. Biceps tendon reattachment - 2. Tennis elbow repair ANKLE - 1. Achilles tendon repair/reconstruction - 2. Lateral stabilization - 3. Medial stabilization at the medial talus site - Foot: Hallux Valgus reconstruction - 4. Midfoot reconstruction KNEH - 1. Medial collateral ligament repair - 2. Lateral collateral ligament repair - 3. Joint capsule closure to anterior proximal tibia - 4. Posterior oblique ligament or joint capsule to tibia repair - 5. Extra capsular reconstruction/ITB tenodesis - 6. Patellar ligament and tendon avulsion repairs ARTHROSCOPIC PROCEDURES SHOULDER - 1. Bankart repair - 2. SLAP lesion repair - 3. Rotator cuff repair 4. Capsule shift repair (glenoid rim)
Product codes (comma separated list FDA assigned to the subject device)
GAM, MAI
Device Description
The PANALOK Loop Anchor System is a preloaded absorbable disposable suture anchor/inserter assembly designed to allow soft tissue repair to bone. The absorbable poly lactic acid (PLA) anchor is the identical anchor as that of the BIOKNOTLESS Anchor in design, configuration and dimensions. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(L-lactide) polymer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Elbow, Ankle, Foot, Knee
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)
Biocompatibility studies have demonstrated the Panalok Loop Anchor to be non-toxic, non-irritating, and non-cytotoxic.
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.
Not Found
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K040827 (pg 1.053)
SECTION 2 – 510(k) SUMMARY
APR 3 0 2004 | Panalok Loop Anchor |
---|---|
Submitter's Name and | |
Address: | DePuy Mitck |
a Johnson & Johnson Company | |
249 Vanderbilt Avenue | |
Norwood, MA 02062 | |
Contact Person | Allyson Barford |
Regulatory Affairs Associate | |
DePuy Mitek | |
a Johnson & Johnson Company | |
249 Vanderbilt Avenue | |
Norwood, MA 02062 | |
Telephone: 781-251-2794 | |
Facsimile: 781-278-9578 | |
e-mail: abarford@dpyus.jnj.com | |
Name of Medical Device | Classification Name: Screw, Fixation, Bone Staple |
Common/Usual Name: Appliance for reconstruction of bone to | |
soft tissue | |
Proprietary Name: Panalok Loop Anchor | |
Substantial Equivalence | The Panalok Loop Anchor is substantially equivalent to the |
BioKnotless Anchor (K002639) and has similar indications to | |
PANALOK Anchor System (K970896) manufactured by DePuy | |
Mitck, a Johnson & Johnson Company, 249 Vanderbilt Avenue, | |
Norwood, MA 02062. | |
Device Classification | Bone anchors/screws are classified by FDA as a Class II Medical |
Devices under the generic category of Single/Multiple Component | |
Metallic Bone Fixation Appliances, Orthopedic Devices Panel | |
(reference 21 CFR §888.3030). Product codes GAM and MAI. | |
Device Description | The PANALOK Loop Anchor System is a preloaded absorbable |
Special 510(k) Premarket Notification: Panalok Loop Anchor | CONFIDENTIAL |
DePuy Mitek
:
1
K040827 (pg 2 of 3)
disposable suture anchor/inserter assembly designed to allow soft tissue repair to bone. The absorbable poly lactic acid (PLA) anchor is the identical anchor as that of the BIOKNOTLESS Anchor in design, configuration and dimensions. The absorbable anchor is a one-piece suture anchor constructed of molded Poly(L-lactide) polymer.
Indications for Use
The Panalok Loop Anchor is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:
OPEN PROCEDURES
- SHOULDER
-
- Bankart repair
-
- SLAP lesion repair
-
- Rotator cuff repair
- 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site
- 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus
-
- Biceps tenodesis
-
- Acromio-clavicular separation
-
- Deltoid repair
ELBOW
-
- Biceps tendon reattachment
-
- Tennis elbow repair
ANKLE
-
- Achilles tendon repair/reconstruction
-
- Lateral stabilization
-
- Medial stabilization at the medial talus site
- Foot: Hallux Valgus reconstruction
-
- Midfoot reconstruction
KNEH
-
- Medial collateral ligament repair
-
- Lateral collateral ligament repair
-
- Joint capsule closure to anterior proximal tibia
-
- Posterior oblique ligament or joint capsule to tibia repair
-
- Extra capsular reconstruction/ITB tenodesis
-
- Patellar ligament and tendon avulsion repairs
ARTHROSCOPIC PROCEDURES SHOULDER
-
- Bankart repair
-
- SLAP lesion repair
-
- Rotator cuff repair
CONFIDENTIAL
2
V.040827 (pg 3 of 3)
- Capsule shift repair (glenoid rim)
Safety
Biocompatibility studies have demonstrated the Panalok Loop Anchor to be non-toxic, non-irritating, and non-cytotoxic.
CONFIDENTIAL
3
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2004
Ms. Allyson Barford Regulatory Affairs Associate DePuy Mitek a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062
Rc: K040827
Trade/Device Name: Panalok Loop Anchor Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L-lactide) surgical suture Regulatory Class: Class II Product Code: GAM, MAI Dated: March 22, 2004 Received: April 2, 2004
Dear Ms. Barford:
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 markcted predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Mcdical 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 such 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); 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.
4
Page 2 - Ms. Allyson Barford
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
(fg 1 of 2)
510(k) Number (if known): K040827
Device Name: Panalok Loop Anchor
Indications For Use:
The PANALOK Loop Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization as follows:
OPEN PROCEDURES
SHOULDER
-
- Bankart repair
-
- SLAP lesion repair
-
- Rotator cuff repair
- 4a. Capsule shift/capsulo-labral reconstruction, at the anterior glenoid rim site
- 4b. Capsule shift/capsulo-labral reconstruction at the lesser tuberosity of the humerus
-
- Biceps tenodesis
-
- Acromio-clavicular separation
-
- Deltoid repair
ELBOW
-
- Biccps tendon reattachment
-
- Tennis elbow repair
ANKLE
-
- Achilles tendon repair/reconstruction
-
- Lateral stabilization
-
- Medial stabilization at the medial talus site
- Foot: Hallux Valgus reconstruction
-
- Midfoot reconstruction
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Milkerson
ral, Restorative, Page 1 of 2 and Neurological Devices
510(k) Number
6
fy 2 of
KNEE
-
Medial collateral ligament repair
-
Lateral collateral ligament repair
-
Joint capsule closure to anterior proximal tibia
-
Posterior oblique ligament or joint capsule to tibia repair
-
Extra capsular reconstruction/ITB tenodesis
-
Patellar ligament and tendon avulsion repairs ・・・
ARTHROSCOPIC PROCEDURES
SHOULDER
-
Bankart repair
-
SLAP lesion repair
-
Rotator cuff repair
-
Capsule shift repair (glenoid rim)