(90 days)
The Sulzer Spine-Tech RPX™ Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
The RPX™ Cement Restrictor is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.
The RPX™ Cement Restrictor Device is a hollow, tapered block that is titanium. This device is intended to be used in conjunction with PMMA cement.
The provided text describes a 510(k) premarket notification for a medical device, the Sulzer Spine-Tech RPX™ Titanium Cement Restrictor. This submission is for regulatory clearance based on substantial equivalence to predicate devices, not for demonstrating clinical efficacy or performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study details, expert consensus, ground truth, and sample sizes is not applicable to this type of regulatory submission as presented in the provided document.
Here's a breakdown of what can be extracted and what is not available:
1. A table of acceptance criteria and the reported device performance
- Not applicable. This document is a 510(k) summary, which focuses on substantial equivalence based on intended use, design, and physical characteristics comparison to predicate devices, rather than establishing specific performance metrics against pre-defined acceptance criteria through a clinical study. Performance data, if any, for mechanical or functional aspects would typically be presented in the full 510(k) submission, not in this summary, and would usually relate to bench testing rather than clinical performance against acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. No test set or clinical study data is mentioned in this 510(k) summary. This submission relies on a comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No test set requiring expert-established ground truth is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a cement restrictor, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth data is established or used for this 510(k) submission.
8. The sample size for the training set
- Not applicable. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. No training set and therefore no ground truth for it.
In summary: The provided document is a 510(k) submission for substantial equivalence. It does not contain information about clinical studies with acceptance criteria, test sets, training sets, ground truth establishment, or expert reviews, as these are typically part of a different type of regulatory submission (e.g., PMA for novel devices or specific clinical studies for efficacy claims). The basis for clearance here is the similarity to existing, legally marketed predicate devices.
{0}------------------------------------------------
MAY 0 2 2002
KO20344
10+2
Sulzer Spine-Tech
510(k) Summary (21 CFR Part 807.92)
Submitter Information A.
Submitter's Name:
Telephone Number:
Angela Byland
(952) 832-5600
Angela Byland
January 31, 2002
Address:
7375 Bush Lake Road Minneapolis, MN 55439-2027
(952) 857-5631
Fax Number:
Contact Person:
Date Submission Prepared:
Device Information B.
Trade Name: Common or Usual Name:
Classification Name:
Device Classification:
Predicate Devices:
Subject Device Description:
Intended Use:
RPXTM Titanium Cement Restrictor Canal Plug, Cement Restrictor
(per 21 CFR Part 878.3300)
Class II (per 21 CFR Part 878.3300) Panel -Orthopedic
SIGNUS Medizintechnik, GmbH RABEA Cement Restrictor Device (K990345)
Medtronic Sofamor Danek BLOCK CR Cement Restrictor (K013014)
The RPX™ Cement Restrictor Device is a hollow, tapered block that is titanium. This device is intended to be used in conjunction with PMMA cement.
The RPXTM Cement Restrictor is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
The RPXTM Cement Restrictor is NOT intended for any spinal indications.
Sulzer Spine-Tech Ti Cement Restrictor Premarket Notification
Confidential
page 4 of 19
{1}------------------------------------------------
C. Substantial Equivalence
The technological characteristics of the RPX™ Cement Restrictor Device Catheter are similar to the following predicate devices:
-
- RABEA Cement Restrictor Device (K990345), manufactured by SIGNUS Medizintechnik GmbH and cleared by the FDA on July 30, 1999
-
- BLOCK CR -- Titanium (K013014), manufactured by Medtronic Sofamor Danek and cleared by the FDA on October 4, 2001.
Establishment of equivalence is based on similarities of intended use, design, and physical characteristics.
{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 emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right, with flowing lines suggesting movement or progress.
Public Health Service
MAY - 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Angela Byland -Senior Regulatory Affairs Specialist Sulzer Spine-Tech 7375 Bush Lake Road Minneapolis, Minnesota 55439-2027
Re: K020344
Trade/Device Name: RPX™ Titanium Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: January 31, 2002 Received: February 1, 2002
Dear Ms. Byland:
We have reviewed your Section 510(k) premarket 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 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 (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's package insert and also as a Warning on the product label:
WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS.
THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.
{3}------------------------------------------------
Page 2 - Ms. Angela Byland
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 may or day 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 or any 1 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.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification if the limitation statement above is added to your labeling, as described.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
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,
Philip J. Fialing
Statland, M.D., Ph.D. Bernar Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Page 1 of 1
KO20344 510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The Sulzer Spine-Tech RPX™ Cement Restrictor is intended for use as a cement The Butter Spring of Surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement.
The RPX™ Cement Restrictor is not intended for any spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | Mark N Millman |
|---|---|
| (Division Sign-Off) Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K020344 |
| Prescription Use (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter Use (Optional Format 1-2-96) |
Sulzer Spine-Tech Ti Cement Restrictor
Premarket Notification Confidential page 6 of 19
§ 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.