(59 days)
Not Found
Not Found
No
The summary describes a calcium sulfate bone void filler and makes no mention of AI or ML technology.
Yes
The device is intended to be replaced with bone during the healing process, indicating a therapeutic effect.
No
Explanation: The provided text describes Stimulan™ as a bone void filler intended for use in clinical situations where autologous grafts or other bone graft substitutes are undesirable. Its function is to resorb and be replaced by bone during healing. It does not mention any function for identifying, detecting, or monitoring medical conditions or diseases, which are characteristics of a diagnostic device.
No
The device description clearly states it is a physical product (pellets) made from calcium sulfate, not software.
Based on the provided information, Stimulan™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes Stimulan™ as a bone graft substitute used in clinical situations where other grafts are undesirable or unavailable. It is implanted directly into the body to fill bone voids and promote healing.
- Device Description: The device is described as sterile pellets made of calcium sulfate, intended for single patient use and implanted into the body.
- Lack of IVD Characteristics: There is no mention of Stimulan™ being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
Stimulan™ is clearly a medical device intended for surgical implantation and bone regeneration, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
StimulanTM 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. StimulanTM 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
MQV
Device Description
StimulanTM Calcium Sulfate Bone Void Filler pellets are provided sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used in accordance with the device labelling. StimulanTM 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)
Not Found
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.
Not Found
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
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
AUG 4 2000
Summary of Safety and Effectiveness
Koo/24
Biocomposites Ltd Etruscan Street Etruria Stoke-on-Trent ST1 SPO England 44 01782 206500
Trade Name: Stimulan™ Calcium Sulfate Bone Void Filler
Common Name: Calcium Sulfate
Classification Name: Unknown
Stimulan™ Calcium Sulfate Bone Void Filler pellets are provided Description: sterile for single patient use. The biodegradable, radiopaque pellets are resorbed in approximately 30-60 days when used in accordance with the device labelling. Stimulan™ is manufactured from 98% medical grade calcium sulfate dihydrate (CaSO4 . 2H2O) and stearic acid.
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 biodegrable and biocompatible, it may be used at an infected site.
Comparable Features to Predicate Device(s): Features comparable to predicate devices include equivalent design, materials and indications.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 4 2000
Mr. J Stephen Bratt Managing Director Biocomposites Ltd. Etruscan Street, Ethuria, Stoke-on-Trent Staffordshire, ST1 5PQ, England
Re: K001724
Trade Name: Stimulan Calcium Sulfate Pellets Regulatory Class: Unclassified Product Code: MQV Dated: May 22, 2000 Received: May 26, 2000
Dear Mr. Bratt:
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 legally marketed predicate devices marketed in interstate commerce stired in the energence, to 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 Coonisions of the Act. The general control provisions of the Act include requirements for annual provisions of ani-1994 - 1997 - 1997 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 (Fremances I pprovide in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 mopolwaiith 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.
2
Page 2 - Mr. J Stephen Bratt
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) 594-4639. 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 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/dsma/dsmamain.html".
Sincerely yours,
Dmne R. lochner
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
3
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. 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.
e R. bochner.
(Division Sign-Off) Division of General Restorative Devices K001724 510(k) Number