(174 days)
The CEMSTOP cement restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty. The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation.
The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation. Biocompatible, this device is completely resorbed within several days at 37 ℃ and resists the temporary temperature rise generated by polymerisation of acrylic cement. The CEMSTOP Cement Restrictor is available in diameters of 6mm, 8mm, 10mm, 12mm, 14mm, 16mm and 20mm.
This submission is a 510(k) for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through clinical or performance trials. Therefore, much of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth cannot be directly extracted from the provided text.
The core of the document is a 510(k) Summary of Safety and Effectiveness, which declares the device's characteristics and its equivalence to a legally marketed predicate device.
Here's a breakdown of what can be inferred or directly stated, and what cannot:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. 510(k) submissions typically do not include detailed performance acceptance criteria in the same way a clinical trial might for a novel device. The "performance" being demonstrated here is primarily the technological equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided. This is not a study that involved a "test set" in the sense of patient data or clinical samples. The basis for substantial equivalence is "material, design and indications."
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):
This information is not provided. There was no "ground truth" to establish for a test set in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. There was no "test set" or adjudication process described.
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:
This is not applicable. The device is a "CEMSTOP Cement Restrictor," a physical diaphyseal plug, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI performance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. As stated above, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not applicable. The submission relies on demonstrating substantial equivalence to a predicate device based on its design, material, and indications, rather than establishing a new "ground truth" through clinical or laboratory data.
8. The sample size for the training set:
This information is not applicable. There is no "training set" for this type of device submission.
9. How the ground truth for the training set was established:
This information is not applicable. There is no "training set" or "ground truth" establishment in the context of this 510(k) submission.
Summary derived from the document:
The provided document describes a 510(k) submission for the CEMSTOP Cement Restrictor. The submission aims to demonstrate substantial equivalence to a previously marketed predicate device, the BIOSTOP G Cement Restrictor (Landos, Inc.).
The basis for claiming substantial equivalence is that the CEMSTOP Cement Restrictor shares the same technological characteristics (design and material) and indications for use as the predicate device.
Its intended use is as a diaphyseal plug to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty, preventing cement flow and facilitating pressurization. The device is biocompatible and resorbable.
The FDA reviewed the submission and determined that the device is substantially equivalent, allowing it to be marketed. This determination is based on the comparison to the predicate device, not on specific performance criteria met through a detailed study on a "test set."
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MAY = 4 2000
K 993841
510(k) Summary of Safety and Effectiveness
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(1) Submitter's name: Submitter's address: Submitter's telephone number: Contact person: Date summary prepared:
Encore Orthopedics, Inc. 9800 Metric Blvd. Austin. TX 78758 512) 834-6237 Debbie De Los Santos November 3, 1999 -
Trade or proprietary device name: CEMSTOP Cement Restrictor (2) Common or usual name: Cement restrictor Class II Classification name:
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Legally marketed predicate device: BIOSTOP G Cement Restrictor (Landos, Inc.) (3)
(4) Subject device description:
The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation. Biocompatible, this device is completely resorbed within several days at 37 ℃ and resists the temporary temperature rise generated by polymerisation of acrylic cement.
The CEMSTOP Cement Restrictor is available in diameters of 6mm, 8mm, 10mm, 12mm, 14mm, 16mm and 20mm.
(ર) Subject device intended use:
The CEMSTOP cement restrictor is a diaphyseal plug designed to occlude the medullary cavity before the introduction of acrylic cement during total hip arthroplasty. The CEMSTOP restrictor prevents the cement from flowing down the diaphysis and therefore facilitates cement pressurisation.
(6) Technological characteristics:
The CEMSTOP cement restrictor has the same technological characteristics (i.e., design and material) when compared to the predicate devices.
(7) Basis for substantial equivalence:
Features comparable to predicate devices include material, design and indications.
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Image /page/1/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 symbol that resembles a bird or a series of flowing lines, possibly representing human profiles. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 4 2000
Ms. Debbie De Los Santos Regulatory/Clinical Specialist Encore 9800 Metric Boulevard Austin, Texas 78758
Re: K993841 Trade Name: CEMSTOP Cement Restictor Regulatory Class: II Product Code: LZN Dated: March 3, 2000 Received: March 6, 2000
Dear Ms. De Los Santos:
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 control provisions of the Act. The general control 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.
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.
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Page 2 - Ms. Debbie De Los Santos
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific an invitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 1010-11-21 questions on the promotion and advertising of your device, (201) 594-4639. Truuntonally, 101 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 monifacturers 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,
Donne R. Kirchner
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
CEMSTOP Cement Restrictor_ Device Name: _
Indications For Use:
CEMSTOP Cement Restrictor Indications For Use
The CEMSTOP cement restrictor is a diaphyseal plug designed to occlude the medulary carity The CEMS I OF cement restrictor is a diaplyson progetting arthroplasty. The CEMSTOP restrictor before the introduction of acryne commit daring tour any would be facilitates cement pressurisation.
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _X (Per 21 CFR 801.109) OR
Over-The-Counter Use _
(Optional Format 1-2-96)_
Dmn R. Lochner.
(Division Sign-Off) (Division Sign-On)
Division of General Restorative Devices S10(k) Number L99384
§ 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.