(90 days)
Not Found
No
The device description focuses on the physical properties and mechanical function of an absorbable foam plug. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
No
The device is described as an absorbable cement flow restrictor used during orthopedic procedures, not as a device that delivers therapy or treatment.
No
The device is described as an absorbable cement flow restrictor used to plug the intramedullary canal, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical, absorbable foam plug and an insertion tool, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The ImproVise™ Absorbable Cement Flow Restrictor is a physical device intended to be implanted inside the body (in the intramedullary canal) during a surgical procedure. Its function is to physically restrict the flow of bone cement.
- Lack of Specimen Testing: The description does not mention any testing of biological specimens or providing diagnostic information based on such testing.
Therefore, based on the provided information, the ImproVise™ Absorbable Cement Flow Restrictor is a surgical implant/device, not an IVD.
N/A
Intended Use / Indications for Use
The ImproVise™ Absorbable Cement Flow Restrictor is intended for use as an absorbable bone cement flow restrictor for use in the intramedullary canal. This device is not intended for use in the spine.
Product codes (comma separated list FDA assigned to the subject device)
LZN
Device Description
The ImproVise™ Absorbable Cement Flow Restrictor is designed to provide a quick, simple, The improvise - Absorbable Ochton I tramedullary canal with an easy-to-place absorbable and chective method of playing the reamer used to form the channel, the appropriate size foam plug. "Dased on the Size of the roamid aboth the canal to the desired depth, using the Cement resultion is scieolor and is them garded onto the tip of the tool. The ImproVise™ Improvise - Inscrition tool. I lago will be progular shape of the canal, effectively toam plugs are deformable and bank tans on the it restrictors are available in sizes small, sealing the canar at the motion in point. The sements of 9.5-11 mm, 11-13 mm, 13-15 mm, medium, large and extraight cylindrical and tapered versions. The restrictor can be aria 13-17.5 min), both in struight bylindhour and or a careery or press-fit into the bone. The ImproVise™ easily Carved with a scalper at the time of ourger, or proprietary polylactic acid foam. Absorbance Ocmont How Receivere which is greater than 90% void space.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intramedullary canal; long bones
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital operating room
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)
Performance: Interference fit that provides 100N push-out force 1.9-2.9 mm.
Safety Characteristics: Biocompatibility of material, demonstrated push-out forces.
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
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
510(k) Summary
Class II
LZN
Kensey Nash Corporation
55 East Uwchlan Avenue
Exton, PA 19341 USA
Koi194/3
Company: Address:
Phone: Fax:
Proprietary Name: Common Name: Classification Name and Reference: Proposed Regulatory Class: Device Product Code:
610-524-0188 610-524-0265 ImproVise™ Absorbable Cement Flow Restrictor Bone Plug Cement Obturator (reference unknown)
For information, contact:
Robin M. Fatzinger Requlatory Affairs Manager Telephone: (610) 594-7146 Fax: (610) 524-0265 Email: r.fatzinger@kenseynash.com
June 20, 2001
Date Summary Prepared: Device Description:
The ImproVise™ Absorbable Cement Flow Restrictor is designed to provide a quick, simple, The improvise - Absorbable Ochton I tramedullary canal with an easy-to-place absorbable and chective method of playing the reamer used to form the channel, the appropriate size foam plug. "Dased on the Size of the roamid aboth the canal to the desired depth, using the Cement resultion is scieolor and is them garded onto the tip of the tool. The ImproVise™ Improvise - Inscrition tool. I lago will be progular shape of the canal, effectively toam plugs are deformable and bank tans on the it restrictors are available in sizes small, sealing the canar at the motion in point. The sements of 9.5-11 mm, 11-13 mm, 13-15 mm, medium, large and extraight cylindrical and tapered versions. The restrictor can be aria 13-17.5 min), both in struight bylindhour and or a careery or press-fit into the bone. The ImproVise™ easily Carved with a scalper at the time of ourger, or proprietary polylactic acid foam.
Absorbable Cement Flow Restrictor is manufactured from a propriet Absorbance Ocmont How Receivere which is greater than 90% void space.
Intended Use:
The ImproVise™ Absorbable Cement Flow Restrictor is intended for use as an absorbable The improvise - Absorbable our for use in the intramedullary canal. This device is not intended for use in the spine.
Substantial Equivalence:
Stantial Equivalenoo.
The intended use, material and design of the ImproVise™ Absorbank Flow The liftended use, material and thus substantially equivalent to the Resorbapliug™ Bone Resultion are heany lightlear and this Gabor Danek division of Medtronic, Inc.) (K920118). See Table 1 below for a comparison of the two devices.
Revised December 12, 2001.
1
| | ImproVise™
Absorbable Cement Flow Restrictor
(Kensey Nash Corporation) | Resorbaplug™ Bone Plug
(Danek Group) |
|-------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Status | New Device | Predicate |
| Intended Use | Bone cement flow restrictor for intra-
medullary canal | Bone cement flow restrictor for
intramedullary canal |
| Target Population | Patients undergoing orthopedic
procedures (large joint replacement
requiring use of bone cement) | Patients undergoing orthopedic
procedures (large joint
replacement requiring use of
bone cement) |
| Anatomical Sites of Use | Orthopedic procedures in the long bones | Orthopedic procedures in the long
bones |
| Material | Polylactic acid | Polylactic acid |
| Architecture | Foam | Foam |
| Manufacturing Process | Proprietary foaming process | Proprietary foaming process |
| Shape | Cone, cylinder | Cone, cylinder |
| Size | Small (9.5-11 mm), medium (11-13 mm),
large (13-15 mm), and extra-large (15-
17.5 mm) | 14, 20 and 26 mm in diameter |
| Sterilization | Gamma radiation | Gamma radiation |
| Where Used | Hospital operating room | Hospital operating room |
| Principle of Operation | Foam plug conforms to shape of
intramedullary canal and is friction fit to
proper depth; plug prevents bone
cement from migrating deeper into the
canal. | Foam plug conforms to shape of
intramedullary canal and is friction
fit to proper depth; plug prevents
bone cement from migrating
deeper into the canal. |
| Performance
Interference fit that
provides 100N push-out
force | 1.9-2.9 mm | 2.5 mm |
| Safety Characteristics | Biocompatibility of material,
demonstrated push-out forces | Biocompatibility of material,
demonstrated push-out forces |
Table 1: Substantial Equivalence of ImproVise™ and Resorbaplug™
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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.
Public Health Service
SEP 1 9 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Julie N. Broderick Vice President of Clinical and Regulatory Affairs Kensey Nash Corporation 55 East Uwchlan Avenue Exton, Pennsylvania 19341
Re: K011943
Trade/Device Name: Impro Vise™ Absorbable Cement Flow Restrictor Regulation Number: 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: LZN Dated: June 20, 2001 Received: June 21, 2001
Dear Ms. Broderick:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have leviewed your becaon o r (x) presses is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of to charactment date of the Medical Device Amendments, or to Commerce proof to May 20, 1978, are cassified in accordance with 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 Tournal controls provisions of the Act include requirements for annual registration, listing of general obliness provided in a sactice, 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 If your device is exactined (tional 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 r toase of action and I Draination that your device complies with other requirements of the Act that I Dr has intact a avoid regulations administered by other Federal agencies. You must of any I catal suttated and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in also qualis) 25 total provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Julie N. Broderick
This letter will allow you to begin marketing your device as described in your Section 510(k) I ma lotter will and in yourse FDA finding of substantial equivalence of your device to a legally premaince noticate 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 21 CFR Part 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" (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,
Sus-Walk, us
$\infty$
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Celia M. Witten, Ph.D., M.D.
Enclosure
4
INDICATIONS FOR USE
510(K) NUMBER (IF KNOWN):
DEVICE NAME: ImproVise™ Absorbable Cement Flow Restrictor
or
INDICATIONS FOR USE:
The ImproVise™ Absorbable Cement Flow Restrictor is intended for use as an absorbable The Inford ISC Ausorbable Coment In the intramedullary canal. This device is not intended for use in the spine.
Please do not write below this line – Use another page if necded
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use I (per 21 CFR 801.109) Over-the-counter Use _________
SR
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011943
003