(211 days)
BioGeneration - ProFusion Bone Graft Substitute
No
The summary describes a calcium sulfate bone void filler and does not mention any AI or ML components or functionalities.
Yes
The device is intended to be used in clinical situations to replace bone during the healing process, demonstrating a therapeutic effect.
No
Explanation: The provided text describes Stimulan™ as a bone void filler intended to be replaced by bone during healing, indicating it is a therapeutic device rather than a diagnostic one. Its function is to treat a condition by filling voids and promoting bone growth, not to diagnose a disease or condition.
No
The device description clearly states it is a physical product (pellets) made from calcium sulfate, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes Stimulan™ as a bone void filler used in clinical situations where bone grafts are undesirable. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details the composition and physical properties of the pellets, which are implanted into the body. IVDs are typically used to examine samples taken from the body (like blood, urine, or tissue) to diagnose or monitor a condition.
- Lack of Diagnostic Function: There is no mention of Stimulan™ being used to detect, measure, or analyze any biological markers or substances for diagnostic purposes.
- Anatomical Site: The device is used in a "Bone void," which is a physical location within the body, not a sample being analyzed.
In summary, Stimulan™ is a therapeutic device used to fill bone voids and aid in bone healing, not a diagnostic device used to analyze samples for diagnostic information.
N/A
Intended Use / Indications for Use
Stimulan™ is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes may be undesirable, due either to the risk of associated infection or unavailability. Stimulan™ is manufactured from medical grade calcium sulfate that resorbs and is replaced with bone during the healing process. Also, as the implant is biodegradable and biocompatible, it may be used at an infected site.
Product codes
MOV
Device Description
Stimulan™ Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 pans when used in accordance with the device labeling. Stimulan™ is manufactured from 98% medical grade calcium sulfate dihydrate (CaSO4 - 2H2O) and stearic acid.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 demonstrated that Stimulan™ has equivalent dissolution, mechanical and mass to volume ratio characteristics to the predicate device. Testing indicated that the product is non-pyrogenic.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Wright Medical - Osteoset Pellets
Reference Device(s)
BioGeneration - ProFusion Bone Graft Substitute
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
0
2/26/99
K 982663
510(k) Summary
Encore Orthopedics, Inc. Submitter's Name: 9800 Metric Blvd., Austin, TX 78758 Submitter's Address: Submitter's Telephone Number: (512) 834-6237 Debbie De Los Santos Contact Person: July 30, 1998 Submission Date: Stimulan™ Calcium Sulfate Bone Void Filler Trade Name: Calcium Sulfate Common Name: Unknown Classification Name: Wright Medical - Osteoset Pellets Legally Marketed Predicate Device: BioGeneration - ProFusion Bone Graft Substitute
Device Description:
Stimulan™ Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 pans when used in accordance with the device labeling. Stimulan™ is manufactured from 98% medical grade calcium sulfate dihydrate (CaSO4 - 2H2O) and stearic acid.
Indications For Use:
Stimulan™ is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes may be undesirable, due either to the risk of associated infection or unavailability. Stimulan™ is manufactured from medical grade calcium sulfate that resorbs and is replaced with bone during the healing process. Also, as the implant is biodegradable and biocompatible, it may be used at an infected site.
Technological Characteristics:
Stimulan™ has the equivalent technological characteristics (i.e. chemical composition, and dissolution rate performance as the predicate device.
Performance Date:
Testing demonstrated that Stimulan™ has equivalent dissolution, mechanical and mass to volume ratio characteristics to the predicate device. Testing indicated that the product is non-pyrogenic.
Basis for Substantial Equivalence:
Stimulan™ is safe and effective because it is equivalent to the predicate device in terms of chemical composition, indication of use, and product performances.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, arranged in a row. The profiles are connected by a flowing line that forms the shape of a wave or ribbon. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 6 1999
Ms. Debbie De Los Santos Regulatory/Clinical Specialist Encore Orthopedics 9800 Metric Boulevard Austin, Texas 78758
K982663 Re : Stimulan™ - Calcium Sulfate Bone Void Filler Trade Name: Unclassified Regulatory Class: MOV Product Code: January 29, 1999 Dated: February 5, 1999 Received:
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 realour bood 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 be Babyers 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 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 requlations.
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Page 2 - Ms. Debbie De Los Santos
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in jour can equivalence of your device to a legally rinang or edicate device results in a classification for your marketca produces of mits 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 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 che promotion and 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
3
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Stimulan™
Indications For Use
Stimulan™ is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes may be undesirable, due either to the risk of associated infection or unavailability. Stimular™ is manufactured from medical grade calcium sulfate that resorbs and is replaced with bone during the healing process. Also, as the implant is biodegradable and biocompatible, it may be used at an infected site.
(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)_
bracello
(Divisio Divisior 510kl Nr