(80 days)
Not Found
No
The device description and performance studies focus on the physical properties and clinical outcomes of resorbable implants, with no mention of AI or ML technology.
Yes
The device is described as an implant used for the "temporary treatment and repair of laryngotracheal fractures and laryngotracheomalacia and lumen augmentation in the temporary treatment and repair of glottic stenosis," which indicates a therapeutic purpose.
No
Explanation: The device is described as an implant used for the temporary treatment and repair of laryngotracheal fractures, laryngotracheomalacia, and lumen augmentation for glottic stenosis. Its function is to provide physical support and facilitate healing, not to diagnose conditions.
No
The device description clearly details physical implants (mesh sheets, graft plates, screws) made of Lactosorb®, which are hardware components. There is no mention of any software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Lorenz Lactosorb® Resorbable Laryngotracheal Reconstruction Implants are physical implants intended to be surgically placed within the body to repair and support structures in the laryngotracheal area. They are used for temporary treatment and repair of physical conditions like fractures, malacia, and stenosis.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, this device falls under the category of a surgical implant or medical device used for structural support and repair, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Lorenz Lactosorb® Resorbable Laryngotracheal Reconstruction Implants are intended to be used for the temporary treatment and repair of laryngotracheal fractures and laryngotracheomalacia and lumen augmentation in the temporary treatment and repair of glottic stenosis.
Product codes (comma separated list FDA assigned to the subject device)
NHB
Device Description
The Lorenz Lactosorb® Laryngotracheal Reconstruction (LTR) Implants consist of mesh sheets for the temporary treatment and repair of laryngotracheal fractures and laryngotracheomalacia, and graft plates for lumen augmentation in the temporary treatment and repair of glottic stenosis. The mesh sheets are 0.75mm thick and 50mm wide by 50mm long. The mesh sheets are offered with two different hole configurations to facilitate attachment to the tracheal cartilage using suture and/or screws. The graft plate is a one-piece device consisting of a rectangular base with an elliptical top. The top is available in widths of 3mm, 4mm, 5mm, and 6mm to allow for various amounts of augmentation of the lumen. The base is 0.5mm thick and 10mm wide by 15mm long. The base has holes around the outer edges to allow for fixation to the tracheal cartilage using suture and/or screws. The Lactosorb® Screws and Lactosorb® Direct Drive Screws have a 1.5 diameter with a range of lengths available from 3 to 8mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
laryngotracheal, glottic
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)
Non - Clinical Testing: Animal studies have been undertaken demonstrating the acceptability of Lactosorb® implants for laryngotracheal reconstruction. From these studies it has been concluded that Lactosorb® implants represent an advancement in the management of tracheomalacia and other conditions requiring temporary airway stenting, including graft procedures.
Clinical Testing: Studies have been undertaken demonstrating the acceptability of Lactosorb® implants for laryngotracheal reconstruction. From these studies it has been concluded that Lactosorb® implants were well tolerated by tissue and provided adequate support for healing of bone and cartilage, along with the potential advantage of a lack of interference with growth.
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
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.
0
OCT 1 8 2001
Summary of Safety and Effectiveness
Specification Holder:
Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, FL 32218-2480 Establishment Registration: 1032347 Walter Lorenz Surgical, Inc. is a wholly owned subsidiary of Biomet, Inc.
| Contact Person: | Sheryl Malmberg
Walter Lorenz Surgical, Inc.
Jacksonville, FL 32218
Phone: (904) 741-4400 ext. 255
Fax: (904) 741-4500 |
| ----------------- | ------------------------------------------------------------------------------------------------------------------------------------ |
|---|
Lorenz LactoSorb® Laryngotracheal Reconstruction Implants Proprietary Name:
Ear Nose & Throat Synthetic Polymer Material Common Name:
Classification Name: 21 CFR 874.3620
Legally Marketed Devices to which substantial Equivalence is Claimed: Eliachar Laryngeal foam Stent (K000154), Lorenz Stent (K896667), and Montgomery Laryngeal Stent (K842287).
Device Description: The Lorenz Lactosorb® Laryngotracheal Reconstruction (LTR) Implants consist of mesh sheets for the temporary treatment and repair of laryngotracheal fractures and laryngotracheomalacia, and graft plates for lumen augmentation in the temporary treatment and repair of glottic stenosis. The mesh sheets are 0.75mm thick and 50mm wide by 50mm long. The mesh sheets are offered with two different hole configurations to facilitate attachment to the tracheal cartilage using suture and/or screws. The graft plate is a one-piece device consisting of a rectangular base with an elliptical top. The top is available in widths of 3mm, 4mm, 5mm, and 6mm to allow for various amounts of augmentation of the lumen. The base is 0.5mm thick and 10mm wide by 15mm long. The base has holes around the outer edges to allow for fixation to the tracheal cartilage using suture and/or screws. The Lactosorb® Screws and Lactosorb® Direct Drive Screws have a 1.5 diameter with a range of lengths available from 3 to 8mm.
Intended Use: The Lorenz Lactosorb® Resorbable Laryngotracheal Reconstruction Implants are intended to be used for the temporary treatment and repair of laryngotracheal fractures and laryngotracheomalacia and lumen augmentation in the temporary treatment and repair of glottic stenosis.
1
Summary of Technologies:
| Comparison
Information | Lorenz Lactosorb®
Laryngotracheal
Reconstruction
Implants | Eliachar Laryngeal
Foam Stent | Lorenz Stent | Montgomery
Lryngeal Stent |
|---------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Walter Lorenz
Surgical, Inc. | Hood Laboratories | Walter Lorenz
Surgical, Inc. | Boston Medical
Products, Inc. |
| 510(k) | New | K000154 | K896667 | K842287 |
| Indications for Use | Reconstruction for
stenosis,
tracheomalacia, and
laryngeal fracture. | Reconstruction for
stenosis and
laryngeal fracture. | Glottic and
subglottic stenosis
aud upper tracheal
stenois with or
without laryngeal
stenosis | For the prevention
and treatment of
laryngeal stenosis
when the glottic
stenosis involves
the midglottis,
posterior glottis,
supraglottis, and
subglottis,
singularly or in
combination. |
| Design | Prefabricated | Prefabricated | Prefabricated | Prefabricated |
| Material | Lactosorb® | Silicone Foam | PTFE | Silicone |
| Sizes | 50 x 50mm mesh,
50 x 50mm sheet
15 x 10mm plate
with 4 available top
width sizes (3,4,5,
and 6mm) | 2 sizes: 25mm,
40mm, 15mm and
25mm, 52mm,
17mm | 16 sizes, ranging
from 6 mm to
18mm | Child, Small Adult,
Medium Adult, and
Large Adult |
| Method of Placement | Screws and/or
Sutures | Adherence to
laryngeal contours
with strap for
additional control
and anchoring | Sutures | Sutures with
silicone buttons |
| Method of
Deployment | Not applicable | Not applicable | Not applicable | Not applicable |
Non - Clinical Testing: Animal studies have been undertaken demonstrating the acceptability of Lactosorb® implants for laryngotracheal reconstruction. From these studies it has been concluded that Lactosorb® implants represent an advancement in the management of tracheomalacia and other conditions requiring temporary airway stenting, including graft procedures.
Studies have been undertaken demonstrating the acceptability of Lactosorb® Clinical Testing: implants for laryngotracheal reconstruction. From these studies it has been concluded that Lactosorb® implants were well tolerated by tissue and provided adequate support for healing of bone and cartilage, along with the potential advantage of a lack of interference with growth.
Lactosorb is a trademark of Biomet, Inc.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with a human profile visible in the negative space between the wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2001
Walter Lorenz Surgical, Inc. c/o Ms. Sheryl Malmerg Regulatory Manager 1520 Tradeport Drive Jacksonville, FL 32218-2480
Re: K012409
Trade/Device Name: Lorenz Resorbable Laryngotracheal Reconstruction Implants Regulation Number: 21 CFR 874.3620 Regulation Name: Ear Nose and Throat Synthetic Polymer Material Regulatory Class: II Product Code: NHB Dated: July 19, 2001 Received: July 30, 2001
Dear Ms. Malmerg:
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 marketed predicate 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) 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.
3
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 presidents in a classification for your device and thus, permits 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
4
STATEMENT OF INDICATIONS FOR USE
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: Lorenz Resorbable Laryngotracheal Reconstruction Implants
Indications For Use:
The Lorenz Resorbable Laryngotracheal Reconstruction Implants are intended to be used for the The Lorenz Resorbable Laryligotracheal Recomed Seconders, Maryneofracheomalacia, and lumen temporaly treatment and repair of raily agently of glottic stenosis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter-Use (Optional Format 1-2-96) |
|---|---|---|---|
| --------------------------------------- | ---------------------------------------------------------------- | ---- | ----------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Ophthalmic Devices | |
| 510(k) Number | 2012409 |
001