(200 days)
MOV
Not Found
No
The 510(k) summary describes a bone void filler material and its intended use, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes
The device is intended to fill bone voids and resorbs to be replaced by bone during the healing process, aiming to treat bone defects and promote healing.
No
The device is described as a bone void filler and bone graft substitute, intended for therapeutic use in filling bone voids or gaps, not for diagnosing medical conditions.
No
The device description clearly states it is presented as a powder and mixing solution that forms a paste, indicating it is a physical material intended for implantation, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Stimulan Kit/Stimulan Rapid Cure's Intended Use: The intended use clearly states that this device is a bone void filler intended to be implanted into bony voids or gaps of the skeletal system. It is a material that is placed directly into the body to aid in bone healing.
- Device Description: The device description confirms it is presented as a powder and mixing solution that forms a paste for implantation.
The function of this device is to physically fill a void within the body and promote bone healing, which is a direct therapeutic intervention, not an in vitro examination of a specimen to provide diagnostic information.
N/A
Intended Use / Indications for Use
Stimulan Kit/Stimulan Rapid Cure is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created from traumatic injury to the bone. Stimulan Kit/Stimulan Rapid Cure is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities, pelvis, and posterolateral spine). Stimulan Rapid Cure provides a bone graft substitute that resorbs and is replaced with bone during the healing process. Stimulan Rapid Cure is biodegradable and biocompatible and may be used at an infected site.
To fill a bone void or defect created by:
- . surgery
- . a cyst
- a tumour .
- . osteomyelitis
- . traumatic injury
Product codes
MOV
Device Description
Stimulan Kit/Stimulan Rapid Cure are indicated to be implanted into defects not intrinsic to the structural stability of the skeletal system. Stimulan Kit/Stimulan Rapid Cure are biocompatible and may be implanted at an infected site. Stimulan Kit/Stimulan Rapid Cure are presented as a powder and mixing solution which when mixed together form a paste which may be injected, digitally implanted or applied to the mold provided to produce pellets.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., extremities, pelvis, and posterolateral spine)
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)
Clinical performance data was not required as the labelling modifications do not affect the safety and effectiveness of the modified device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2015
Biocomposites Ltd Mr. Simon Fitzer Keele Science Park Keele Staffordshire ST5 SNL United Kingdom
Re: K141830
Trade/Device Name: Stimulan Kit/Stimulan Rapid Cure Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: December 22, 2014 Received: December 24, 2014
Dear Mr. Fitzer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional 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 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 comply with all the Act's requirements, including, but not limited to: registration and listing
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Page 2 – Mr. Simon Fitzer
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K141830
Device Name
Stimulan Kit/Stimulan Rapid Cure
Indications for Use (Describe)
Stimulan Kit/Stimulan Rapid Cure is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created from traumatic injury to the bone. Stimulan Kit/Stimulan Rapid Cure is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities, pelvis, and posterolateral spine). Stimulan Rapid Cure provides a bone graft substitute that resorbs and is replaced with bone during the healing process. Stimulan Rapid Cure is biodegradable and biocompatible and may be used at an infected site.
To fill a bone void or defect created by:
- . surgery
- . a cyst
- a tumour .
- . osteomyelitis
- . traumatic injury
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY . . . . . . . . . . . . . . . . .
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR807.92(c), the following information serves as a Summary of Safety and Effectiveness for the use of Stimulan Kit/Stimulan Rapid Cure.
| 1. | Submitted by: | Biocomposites Ltd
Keele Science Park
Keele
Staffordshire
ST5 5NL
England |
|----|-------------------|-----------------------------------------------------------------------------------------|
| | Date: | January 23, 2015 |
| | Contact Person: | Simon Fitzer
Regulatory
Tel: +44 (0) 1782 338580
Fax: +44 (0) 1782 338599 |
| 2. | Proprietary Name: | Stimulan Kit/Stimulan Rapid Cure |
| | Common Name: | Bone Void Filler |
21 CFR 888.3045 – Class II Classification:
Product Code/Panel: MQV/Orthopedic
-
- Pimary Predicate Device: K021551- Stimulan Kit
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4. Device Description
Stimulan Kit/Stimulan Rapid Cure are indicated to be implanted into defects not intrinsic to the structural stability of the skeletal system. Stimulan Kit/Stimulan Rapid Cure are biocompatible and may be implanted at an infected site. Stimulan Kit/Stimulan Rapid Cure are presented as a powder and mixing solution which when mixed together form a paste which may be injected, digitally implanted or applied to the mold provided to produce pellets.
5. Materials
Stimulan Kit/Stimulan Rapid Cure are manufactured from medical grade calcium sulfate. Stimulan Kit/Stimulan Rapid Cure resorbs and is replaced by bone during the healing process.
6. Intended Use
Stimulan Kit/Stimulan Rapid Cure is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created from traumatic injury to the bone. Stimulan Kit/Stimulan Rapid Cure is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., extremities, pelvis, and posterolateral spine). Stimulan Kit/Stimulan Rapid Cure provides a bone graft substitute that resorbs and is replaced with bone during the healing Stimulan Kit/Stimulan Rapid Cure is biodegradable and process. biocompatible and may be used at an infected site.
To fill a bone void or defect created by:
- surgery •
- . a cyst
- a tumour
- . osteomyelitis
- . traumatic injury
5
7. Technological Characteristics Comparison
The technological characteristics have not changed as a result of the labeling modification.
8. Substantial Equivalence - Non - Clinical Evidence
Design controls were implemented following risk analysis. No new risks were identified demonstrating that the modified device is substantially equivalent to the predicate device.
Substantial Equivalence - Clinical Evidence 9.
Clinical performance data was not required as the labelling modifications do not affect the safety and effectiveness of the modified device.
10. Substantial Equivalence - Conclusions
The labeling modifications made do not raise any new concerns regarding safety and effectiveness. The information provided supports that the modified Stimulan Kit/Stimulan Rapid Cure is substantially equivalent to the predicate device.