(117 days)
No
The summary describes a bone void filler and a syringe system, with no mention of AI or ML capabilities.
Yes
The device is intended to treat surgically created osseous defects or those resulting from traumatic injury by filling bone voids, indicating a therapeutic purpose.
No
This device is a bone void filler intended for use in treating surgically created or traumatically induced osseous defects, and for delivering material to an orthopedic surgical site. It does not perform any diagnostic functions.
No
The device description clearly outlines physical components including a cartridge, syringe, and adapter valve, indicating it is a hardware device, not software-only.
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 a bone void filler for surgical use in the skeletal system. It is used in vivo (within the body) to fill gaps and voids in bone and is replaced by bone during the healing process.
- Device Description: The device description confirms it's a kit containing a bone void filler and syringes for aspiration and delivery. These are all tools and materials used directly in a surgical procedure on a patient.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test samples (blood, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor a disease, or determine compatibility.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device's function is entirely therapeutic and structural, not diagnostic.
N/A
Intended Use / Indications for Use
VITOSS® Scaffold Synthetic Cancellous Bone Void Filler is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. VITOSS Scaffold is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. VITOSS should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
VITOSS Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
The VITOSS-Filled Cartridge is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. This Cartridge provides the surgeon with a convenient way to mix autologous blood or bone marrow with Vitoss Scaffold® and deliver the material to the orthopaedic surgical site.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
The Vitoss-Filled Cartridge is a device that combines two Orthovita products, Vitoss Scaffold Synthetic Cancellous Bone Void Filler (K994337) and the Imbibe II Syringe (K030208) into a kit configuration. The convenience kit provides the Imbibe II Syringe loaded (filled) with Vitoss Scaffold and an empty 30cc secondary syringe (Merit Piston Syringe. K875196). An adapter valve, which can be connected to the vacuum line in the surgical suite, is also provided. The surgeon can use either the secondary syringe or the vacuum line adapter to aspirate blood or marrow into the Vitoss-Filled Cartridge.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e., the extremities, spine and pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon, orthopaedic surgical site
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Orthovita, Inc. Vitoss-Filled Cartridge Special 510(k)
510(k) Summary
Submitted by | Address | Telephone | Contact Person |
---|---|---|---|
OrthoVita, Inc. | 45 Great Valley Parkway | ||
Malvern, PA 19355 | (610) 640-1775 | Andreina Ide | |
Sr. Director, Regulatory | |||
Affairs | |||
September 2002 | Subject Device | Predicate Device | |
Trade Name | Vitoss-Filled Cartridge | Vitoss Scaffold, K994337 and | |
Imbibe II Syringe, K030208 | |||
Common Name | Kit: Bone Void Filler and | ||
Bone Graft Delivery Syringe | Bone Void Filler and | ||
Bone Graft Delivery Syringe | |||
Classification Name | Bone Void Filler and Piston | ||
Syringe | Bone Void Filler and Piston | ||
Syringe |
Device Description:
The Vitoss-Filled Cartridge is a device that combines two Orthovita products, Vitoss Scaffold Synthetic Cancellous Bone Void Filler (K994337) and the Imbibe II Syringe (K030208) into a kit configuration. The convenience kit provides the Imbibe II Syringe loaded (filled) with Vitoss Scaffold and an empty 30cc secondary syringe (Merit Piston Syringe. K875196). An adapter valve, which can be connected to the vacuum line in the surgical suite, is also provided. The surgeon can use either the secondary syringe or the vacuum line adapter to aspirate blood or marrow into the Vitoss-Filled Cartridge.
Intended Use:
VITOSS® Scaffold Synthetic Cancellous Bone Void Filler is intended only for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. VITOSS Scaffold is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. VITOSS should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
VITOSS Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
The Cartridge, containing Vitoss Scaffold, is intended for use as a piston syringe for the aspiration of bone marrow, autologous blood, plasma or other blood components. The cartridge provides the surgeon with a convenient way to mix autologous blood or bone marrow with Vitoss Scaffold Bone Void Filler and deliver the material to the orthopaedic surgical site.
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1
Comparison to Predicate:
The Vitoss-Filled Cartridge claims substantial equivalence to the Vitoss Scaffold Synthetic Cancellous Bone Void Filler (K994337) and the Imbibe II Syringe (K030208), cleared December 14, 2000 and April 16, 2003 respectively.
The Vitoss-Filled Cartridge is a device that combines Vitoss Scaffold (K994337) and the Imbibe II Syringe (K030208) into a convenience kit whereby the Imbibe II Syringe is loaded (filled) with Vitoss Scaffold. No changes have been made to the Vitoss Scaffold or the Imbibe II Syringe.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 2003
Ms. Andreina Ide Sr. Director, Regulatory Affairs Orthovita, Inc. 45 Great Valley Parkway Malvern, PA 19355
Re: K032130
Trade Name: Vitoss Scaffold Synthetic Cancellous Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: October 23, 2003 Received: October 27, 2003
Dear Ms. Ide:
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 applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050
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Page 2 - Ms. Andreina Ide
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 predicate 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.
Sincerery, yours,
Mark A. Milken
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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Orthovita, Inc. Vitoss-Filled Cartridge Special 510(k), K032130
INDICATIONS FOR USE STATEMENT October 30, 2003
510(k) NUMBER (IF KNOWN): K032130
DEVICE NAME: Vitoss-Filled Cartridge
INDICATIONS FOR USE:
VITOSS® Scaffold Synthetic Cancellous Bone Void Filler is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. VITOSS Scaffold is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. VITOSS should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously.
VITOSS Scaffold is intended to be packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) and may be combined with autogenous blood and/or bone marrow. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.
The VITOSS-Filled Cartridge is intended for use as a piston syringe system for the aspiration of autogenous blood and/or bone marrow. This Cartridge provides the surgeon with a convenient way to mix autologous blood or bone marrow with Vitoss Scaffold® and deliver the material to the orthopaedic surgical 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
(Division Sign-Off
Division of General, Restorative and Neurological Devices
510(k) Number K 032130