(89 days)
Not Found
No
The description focuses on a mechanical suture system and its performance in pullout and insertion testing, with no mention of AI or ML.
No.
This device is a suture system intended for soft tissue to bone suture fixation, which is a surgical tool for structural repair rather than a device that provides a therapeutic effect through physiological or pharmacological means.
No
The device is described as a "Suture System" intended for "soft tissue to bone suture fixation" and involves an "anchor" and "suture" to "secure the soft tissue to the bone." This functionality indicates it is a surgical tool for repair and fixation, not a device used to diagnose a medical condition.
No
The device description clearly describes a physical anchor and an introduction device, which are hardware components. The performance studies also focus on the mechanical properties of the device (pullout and insertion testing).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The description of the Multitak Suture System clearly indicates it is a surgical implant used to fix soft tissue to bone within the body. It is a physical device used in surgical procedures, not a test performed on a sample.
The information provided about the device's function, intended use, and performance studies all point to it being a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The devices are intended for soft tissue to bone suture fixation for the following indications:
Shoulder
- Bankart lesion repairs
- S.L.A.P. lesion repairs
- Acromio-clavicular Repairs
- -Capsular Shift/Capsulolabral Reconstruction
- Deltoid Repair
- Rotator cuff tear repairs -
- -Biceps tenodesis
Foot and Ankle
- Medial/lateral repairs, reconstructions
- Achilles tendon repairs ・
- Midfoot and forefoot repairs
- ﮯ Hallux Valgus reconstruction
Elbow
- Ulnar or radial collateral ligament reconstructions -
- -Tennis elbow repair
- ー Biceps tendon reattachment
Knee
- Extra-capsular repairs:
- Medial collateral-ligament--------------------------------------
- Lateral collateral ligament
- Posterior oblique ligament
- Iliotibial band tenodesis *
- -Patellar tendon repair ... ...................................................................................................................................................
- VMO advancement -
- ﻪ Joint capsule closure
Hand/Wrist
- . Collateral ligament repair (Gamekeeper's Thumb)
- Scapholunate ligament reconstruction
- Tendon transfers in phalanx
- Volar plate reconstruction
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC
Device Description
The anchor is tubular in shape and is preassembled threaded with USP size 2-0 through 2 braided polyester suture. An Introduction Device holds the anchor and delivers it into the bone through a predrilled hole. The sutures can then be used to secure the soft tissue to the bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot and Ankle, Elbow, Knee, Hand/Wrist
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)
The Multitak Suture System was compared in pullout testing to the predicate device and found to demonstrate pullout strengths superior to those of a suture only reattachment technique. Insertion testing was performed to verify insertion and locking at all indicated sites.
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.
K934183, K953877, K930892, K904436, K926384, K962397
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
§ 888.3040 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
K97 11414 JUN 25 1997
Summary of Safety and Effectiveness Multitak Suture System™
Submitted by
Bonutti Research, Inc. 1303 Evergreen Ave. Effingham, IL 62401
Prepared by
Lynnette Whitaker Director Regulatory Affairs/Quality Assurance
- Date
June 24, 1997
Trade Name .
Multitak Suture System
Common Name .
Soft Tissue Anchor
Classification Name t
21 CFR 888.3040, Smooth or Threaded Metallic Bone Fixation Fastener
Predicate Devices
- Multitak SS Suture System, manufactured by Bonutti Research, K934183. .
- GII Anchor System, manufactured by Mitek Surgical Products, Inc., . K953877.
- Mini QuickAnchor, manufactured by Mitek Surgical Products, Inc., . K930892 and K904436.
- Statak Soft Tissue Attachment Device, manufactured by Zimmer, Inc., . K926384, cleared November 16, 1993 and K962397, cleared August 27, 1996.
1
1
Device Description
The anchor is tubular in shape and is preassembled threaded with USP size 2-0 through 2 braided polyester suture. An Introduction Device holds the anchor and delivers it into the bone through a predrilled hole. The sutures can then be used to secure the soft tissue to the bone.
Intended Use
The devices are intended for soft tissue to bone suture fixation for the following indications:
Shoulder
- Bankart lesion repairs .
- S.L.A.P. lesion repairs .
- Acromio-clavicular Repairs .
- -Capsular Shift/Capsulolabral Reconstruction
- Deltoid Repair .
- Rotator cuff tear repairs -
- -Biceps tenodesis
Foot and Ankle
- Medial/lateral repairs, reconstructions
- Achilles tendon repairs ・
- Midfoot and forefoot repairs ﻪ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
- ﮯ Hallux Valgus reconstruction
Elbow
•
- Ulnar or radial collateral ligament reconstructions -
- -Tennis elbow repair
- ー Biceps tendon reattachment
Knee
י
- Extra-capsular repairs:
- Medial collateral-ligament--------------------------------------
- Lateral collateral ligament
- Posterior oblique ligament
- Iliotibial band tenodesis *
- -Patellar tendon repair ... ...................................................................................................................................................
- VMO advancement -
- ﻪ Joint capsule closure
Hand/Wrist
-
. Collateral ligament repair (Gamekeeper's Thumb)
2 -
Scapholunate ligament reconstruction
-
Tendon transfers in phalanx
-
Volar plate reconstruction
2
Performance Data
The Multitak Suture System was compared in pullout testing to the predicate device and found to demonstrate pullout strengths superior to those of a suture only reattachment technique. Insertion testing was performed to verify insertion and locking at all indicated sites.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement. The eagle is a prominent symbol, representing the department's role in protecting and promoting the health and well-being of the nation.
.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lynnette Whitaker, RAC Director, Regulatory Affairs/Quality Assurance Bonutti Research, Inc. 1303 Evergreen Avenue Effingham, Illinois 62401
JIN 2 5 1397
K971144 Re : Multitak SS Suture System® Regulatory Class: II Product Codes: MBI and HWC Dated: March 27, 1997 Received: March 28, 1997
Dear Ms. Whitaker:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Lynnette Whitaker, RAC
This letter will allow you to beqin marketinq your device as described in your 510(k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Marie Schroeder, MS, PT
for
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page
510(k) Number (if known):_
Device Name: MULTITAK SUTURE SysTEM
Indications For Use:
The Multitak Suture System is intended for soft tissue to bone suture fixation for the following indications: Knee Shoulder Extra-capsular repairs: Bankart lesion repairs Medial collateral ligament S.L.A.P. lesion repairs Lateral collateral ligament Acromio-clavicular repairs Posterior oblique ligament Capsular shift/capsulolabral reconstruction Iliotibial band tenodesis Deltoid repair
Rotator cuff tear repairs Biceps tenodesis
Foot and Ankle Medial/lateral repairs, reconstructions Achilles tendon repairs (Gamekeeper's Thumb) Midfoot and forefoot repairs Hallux valgus reconstruction
Elbow Ulnar or radial collateral ligament reconstructions Tennis elbow repair Biceps tendon reattachment
Patellar tendon repair VMO advancement Joint capsule closure
Hand/Wrist
Collateral ligament repair Scapholunate ligament reconstruction Tendon transfers in phalanx Volar plate reconstruction
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
oncurrence of CDRH, Office of Device Evaluation (ODE)
Marie H. Schroeder, MS PT fa rmu.
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971144
Prescription Use
(Per 21 CFR 801.109)
ರಿಗ
Over-The-Counter Use
(Optional Format 1-2-96)