(160 days)
Not Found
No
The summary describes a purely mechanical, bioabsorbable fixation device with no mention of software, image processing, or AI/ML terms.
No.
The device is a fixation device used for soft tissue grafts in ACL/PCL reconstruction, which is a structural component for support rather than a device designed to treat or alleviate a disease or condition.
No
Explanation: The device description states that the EndoPearl is a "fixation device" used for "soft tissue grafts on the femoral side of an ACL/PCL reconstruction." This indicates a surgical tool for structural support, not a device used to identify or analyze medical conditions.
No
The device description explicitly states it is a "cannulated, sterile, single-use fixation device made from a bioabsorbable homopolymer," indicating it is a physical hardware device, not software.
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 device is used for fixation of soft tissue grafts during ACL/PCL reconstruction. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a fixation device made from a bioabsorbable material, designed to be implanted in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to be implanted within the body for structural support or fixation.
N/A
Intended Use / Indications for Use
The EndoPearl is used in conjunction with the 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.
Product codes (comma separated list FDA assigned to the subject device)
MAI, HWC
Device Description
The EndoPearl BioAbsorbable Soft Tissue Device is a cannulated, sterile, single-use fixation device made from a bioabsorbable homopolymer, Poly (L-lactic acid) that will qradually be metabolized by the body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral side of an ACL/PCL reconstruction
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)
Testing has been done to prove safety and effectiveness of the device.
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
4/29/99
Image /page/0/Picture/1 description: The image shows the logo for Linvatec. The logo consists of a geometric shape on the left and the word "Linvatec" on the right. The geometric shape is a square with three angled lines inside. The word "Linvatec" is written in a bold, sans-serif font.
11311 Concept Boulevard Largo, Florida 33773-4908 727 392-6464
K98417/
February 9, 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 Effectiveness for the EndoPearl, 510(k) Number K984171.
A. Submitter
Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908
Company Contact B.
Laura Seneff Manager, Regulatory Affairs
c. Device Name
| Trade Name: | : | EndoPearl |
|---|---|---|
| Common Name | : | EndoPearl |
| Classification Names | : | None Assigned |
| Proposed Class/Device | ||
| Product Code | : | Class II-87 MAI, Fastener |
| Fixation, Biodegradable, Soft | ||
| Tissue |
D. Predicate/Legally Marketed Devices
EndoButton Acufex Microsurgical Inc.
1
Summary of Safety and Effectiveness EndoPearl 510 (k) # K984171 February 9, 1999 Page 2 of 3
E. Device Description
BioAbsorbable Soft Tissue Device is ಡಿ The EndoPearl cannulated, sterile, single-use fixation device made from a bioabsorbable homopolymer, Poly (L-lactic acid) that will qradually be metabolized by the body.
F. Intended Use
This device is used in conjunction with the 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.
G. Substantial Equivalence
The EndoPearl is substantially equivalent in function and intended use to the EndoButton (Acufex Microsurgical Inc.) .
Testing has been done to prove safety and effectiveness of the device.
The similarities/dissimilarities to the predicate are shown in the attached table.
2
Summary of Safety and Effectiveness EndoPearl 510(k) # K984171 February 9, 1999 Page 3 of 3
| Company | Device Name | Intended Use | Material | Single-Use
Reusable
Method of
Sterilization | Design |
|----------------------------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| NEW PRODUCT
Linvatec | EndoPearl
BioAbsorbable
Soft Tissue
Device | Used in conjunction
with Linvatec's
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 sizes
Design is a sphere
with a 2mm central
hole. |
| PREDICATE
Acufex
Microsurgical
Inc.
510 (K) #
K922559 | EndoButton | Suture fixation in the
repair of tendons and
ligaments. | Titanium Alloy | Single Use
Gamma
Radiation
Sterilization | Sizes :4mm x 12mm
4mm x 16.5mm
Design is a flat
rectangular plate
with four holes
going across. |
CHART OF SIMILARITIES AND DISSIMILARITIES
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 1999
Ms. Laura Seneff Manager, Regulatory Affairs Linvatec 11311 Concept Boulevard Largo, Florida 33773-4908
K984171 Re: EndoPearl Trade Name: Regulatory Class: II Product Codes: MAI and HWC Dated: February 9, 1999 February 10, 1999 Received:
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 The general controls provisions of the Act 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. ਰੇ 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 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 - Ms. Laura Seneff
This letter will allow you to begin marketing your device as rnio reed in your 510 k) premarket notification. The FDA ating of substantial equivalence of your device to a legally marketed predicate device results in a classification for your marketed predice actits 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 rigro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on obmpriamot as (nd 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
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
February 9, 1999
Page 1 of 1
510(k) Number (if known): K984171
Device Name: EndoPearl
Indications for Use:
The EndoPearl is used in conjunction with the Linvatec BioSo bioabsorbable interference screw, as a back-up to interference screw fixation of soft tissue grafts on the femoral side of ACL/PCL reconstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sign-Off) General Restorative Devices
| Prescription Use | Yes | OR |
|---|---|---|
| (Per 21 CFR 801.109) |
Over-the-Counter Use /