(152 days)
Not Found
No
The 510(k) summary describes a bone void filler material and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is indicated for osseous defect filling, which is a therapeutic intervention aimed at treating bone defects.
No
Explanation: The provided text describes the device as a bone void filler intended for osseous defect filling, which is a therapeutic purpose, not a diagnostic one.
No
The device description explicitly states it is a granular bone void filler consisting of TCP and HA, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "osseous defect filling of bones" and is "gently packed into osseous defects." This describes a device used in vivo (within the body) for a therapeutic or structural purpose.
- Device Description: The description details the material composition (TCP and HA) and its function as a "granular bone void filler." This further supports its use as an implantable or surgically placed material.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples in vitro (outside the body), such as blood, urine, or tissue, to diagnose a condition or provide information about a patient's health status.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
BoneSave™ Calcium phosphate granules (20cc) are indicated for osseous defect filling of bones not intrinsic to stability of the bony structure.
- BoneSave™ Calcium phosphate granules are indicated to be gently packed into osseous . defects (i.e. bony voids or gaps) of the skeletal system (i.e., the extremities, spine, and pelvis).
- These defects may be surgically created osseous defects or osseous defects created from . traumatic injury to the bone.
Product codes
MQV
Device Description
Both the subject device and the predicate Mastergraft™ Resorbable Ceramic Pellets (Medtronic Sofamor Danek) are granular bone void fillers consisting of TCP and HA. The subject device is 80wt.%TCP and 20wt.%HA, while the predicate device can be either 60%HA/40%TCP or 15%HA/85%TCP. The TCP/HA ratio for the subject device falls in between the TCP/HA ratios cleared for the predicate device. Therefore, with regard to materials, the subject and predicate devices are substantially equivalent. The subject and predicate devices are both available in granular (or "pellet") form.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bones not intrinsic to the stability of the bony structure; skeletal system (i.e., the extremities, spine, and pelvis).
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
Laboratory testing and animal testing were provided to characterize the subject device and to allow comparison of its characteristics to predicate devices.
Key Metrics
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
MAR - 9 2004
510(k) Summary: BoneSave™ Bone Void Filler
| Proprietary Name: | BoneSave™ Bone Void Filler |
|---|---|
| Common Name: | Synthetic bone void filler |
| Classification Name and Reference: | Resorbable calcium salt bone void filler |
| device | |
| 21 CFR 888.3045 | |
| Regulatory Class: | Class II |
| Device Product Code: | MQV - Filler, Calcium Sulfate, Preformed |
| Pellet | |
| Predicate Proprietary Name(s): | K991854: Osteoplast Bone Void Filler |
| Pellets (Interpore Cross International) | |
| K020986: Mastergraft™ Resorbable | |
| Ceramic Pellets (Medtronic Sofamor Danek | |
| USA) | |
| Predicate Regulatory Class: | Class II |
| Predicate Product Code(s): | MQV |
| Submitted By: | Howmedica Osteonics Corp. |
| 59 Route 17 | |
| Allendale, New Jersey 07401-1677 | |
| (201) 825-4900 | |
| Contact Information: | Lorraine Montemurro |
| Phone: (201) 831-5892 | |
| Fax: (201) 831-6038 | |
| Date Summary Prepared: | March 5, 2004 |
Description/Technological Comparison
Materials:
Both the subject device and the predicate Mastergraft™ Resorbable Ceramic Pellets (Medtronic Sofamor Danek) are granular bone void fillers consisting of TCP and HA. The subject device is 80wt.%TCP and 20wt.%HA, while the predicate device can be
1
either 60%HA/40%TCP or 15%HA/85%TCP. The TCP/HA ratio for the subject device falls in between the TCP/HA ratios cleared for the predicate device. Therefore, with regard to materials, the subject and predicate devices are substantially equivalent.
Intended Use:
The subject device and the predicate devices have intended use and indications for use. Therefore, with regard to intended use, the subject and predicate devices are substantially equivalent.
Design:
The subject and predicate devices are both available in granular (or "pellet") form. Therefore, with regard to design, the subject and predicate devices are substantially equivalent.
Intended Use
BoneSave™ Calcium phosphate granules (20cc) are indicated for osseous defect filling of bones not intrinsic to stability of the bony structure.
- BoneSave™ Calcium phosphate granules are indicated to be gently packed into . osseous defects (i.e. bony voids or gaps) of the skeletal system (i.e., the extremities, spine, and pelvis).
- These defects may be surgically created osseous defects or osseous defects . created from traumatic injury to the bone.
Testing Summary
Laboratory testing and animal testing were provided to characterize the subject device and to allow comparison of its characteristics to predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 9 2004
Ms. Terry Sheridan Powell Regulatory Affairs Team (Consultant) Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430
Re: K033258
Trade Name: BoneSave™ Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: February 17, 2004 Received: February 18, 2004
Dear Ms. Powell:
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.
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 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 (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 Page 2 - Ms. Terry Sheridan Powell
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applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed preciicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
elia 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): _K033258
:
Device Name: BoneSave™ Bone Void Filler
BoneSave™ Calcium phosphate granules (20cc) are indicated for osseous defect filling of bones not intrinsic to stability of the bony structure.
- BoneSave™ Calcium phosphate granules are indicated to be gently packed into osseous . defects (i.e. bony voids or gaps) of the skeletal system (i.e., the extremities, spine, and pelvis).
- These defects may be surgically created osseous defects or osseous defects created from . traumatic injury to the bone.
Prescription Use X (Part 21 CFR 801 Subart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
1033258 510(k) Number-