(66 days)
Not Found
No
The summary describes a purely mechanical, bioabsorbable fixation device and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
No
This device is a fixation device used in surgical procedures (ACL/PCL reconstruction) to secure soft tissue grafts, not to treat a disease or condition itself.
No
This device is described as a fixation device used in surgical procedures (ACL/PCL reconstruction) to secure soft tissue grafts, not to diagnose a condition.
No
The device description clearly states it is a physical, bioabsorbable fixation device made from Poly (L-lactic acid) and comes preloaded on a suture threader. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of the EndoPearl™ With Threader is for the fixation of soft tissue grafts during ACL/PCL reconstruction, which is a surgical procedure performed directly on the patient's body.
- The device description focuses on its material and function in a surgical context. It describes a bioabsorbable fixation device used in conjunction with a screw, not a reagent or instrument for analyzing biological samples.
- There is no mention of analyzing biological samples or providing diagnostic information. The purpose is mechanical fixation, not diagnosis.
Therefore, the EndoPearl™ With Threader is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EndoPearl™ With Threader is used in conjunction with a Invatec BioScrew® bioabsorbable interference screw, as a back-up to interference screw fixation of soft tissue grafts on the femoral side of an ACL/PCL reconstruction.
Product codes
MAI, HWC
Device Description
The EndoPearl™ With Threader Bioabsorbable Soft Tissue Device is a cannulated, sterile, sinqle-use fixation device made from a bioabsorbable homopolymer, Poly (L-lactic acid) that will gradually be metabolized by the body. EndoPearl™ comes preloaded on a suture threader (with The nitinol wire) to facilitate the threading of the suture into EndoPearl™ during graft preparation by the the surgeon, resident, PA, or nurse.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral side
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, resident, PA, or nurse.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K9913339
DEC I 0 1999
October 4, 1999
SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and nereby - Baxaccing - cho Pearl™ With Threader, 510(k) Number
A. Submitter
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
Company Contact B.
Laura Seneff Manager, Regulatory Affairs
Device Name C.
| Trade Name: | : EndoPearl™ With Threader |
|---|---|
| Common Name | : |
| Classification Names | : None Assigned |
| Proposed Class/Device | |
| Product Code | : Class II-87 MAI, Fastener |
| Fixation, Biodegradable, Soft | |
| Tissue |
Predicate/Legally Marketed Devices D.
EndoPearl™ Linvatec Corporation
1
Summary of Safety and Effectiveness
EndoPearl™ With Threader 510(k) # K993339 October 4, 1999 Page 2 of 3
E. Device Description
The EndoPearl™ With Threader Bioabsorbable Soft Tissue Device is a cannulated, sterile, sinqle-use fixation device made from a bioabsorbable homopolymer, Poly (L-lactic acid) that will gradually be metabolized by the body.
EndoPearl™ comes preloaded on a suture threader (with The nitinol wire) to facilitate the threading of the suture into EndoPearl™ during graft preparation by the the surgeon, resident, PA, or nurse.
F. Intended Use
- 1
This device is used in conjunction with a Linvatec BioScrew® bioabsorbable interference screw, as a back-up to interference screw fixation of soft tissue grafts on the femoral side of an ACL/PCL reconstruction.
৫ . Substantial Equivalence
The EndoPearl™ With Threader is substantially equivalent in function and intended use to the EndoPearl™ (Linvatec Corporation) .
The similarities/dissimilarities to the predicate are shown in the attached table.
2
Summary of Safety and Effectiveness EndoPearl™ With Threader 510 (k) # ____________________________________________________________________________________________________________________________________________________________________ Page 3 of 3
�
CHART OF SIMILARITIES AND DISSIMILARITIES
| Company | Device Name | Intended Use | Material | Single-Use
Reusable
Method of
Sterilization | Design |
|------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------|---------------|
| NEW PRODUCT
Linvatec | EndoPearl™
With Threader
Bioabsorbable
Soft Tissue
Device | Used in conjunction
with a Linvatec
BioScrew®
bioabsorbable
interference screw, as
a back-up to
interference screw
fixation of soft
tissue grafts on the
femoral side of an
ACL/PCL
reconstruction. | EndoPearl: Poly (L-lactic
acid)
Threader: Ultem with Nitinol
Wire | Single-Use
ETO | 7mm, 8mm, 9mm |
| PREDICATE
Linvatec
EndoPearl™
510(K) #
K984171 | EndoPearl™ | Used in conjunction
with a Linvatec
BioScrew®
bioabsorbable
interference screw, as
a back-up to
interference screw
fixation of soft
tissue grafts on the
femoral side of an
ACL/PCL
reconstruction. | Poly (L-lactic acid) | Single-Use
ETO | 7mm, 8mm, 9mm |
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles an eagle or other bird with its wings spread. The emblem is stylized and appears to be composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 1999
Ms. Laura Seneff Manager. Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
Re: K993339
Trade Name: EndoPearI™ With Threader Regulatory Class: II Product Code: MAI and HWC Dated: October 4, 1999 Received: October 5, 1999
Dear Ms. Seneff:
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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 action. In addition, FDA may publish further announcements 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 - Ms. Laura Seneff
This letter will allow you to begin marketing your device as described in your 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 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 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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
October 4, 1999
Page 1 of 2
510(k) Number (if known):_K993339
Device Name: EndoPearl™ With Threader
Indications for Use:
The EndoPearl™ With Threader is used in conjunction with a Invatec BioScrew® bioabsorbable interference screw, as a back-up to interference screw fixation of soft tissue grafts on the femoral side of an ACL/PCL reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use___________OR
Over-the-Counter Use_
(Per 21 CFR 801.109)
(Optional Format 1-296)
Acolla