(160 days)
Not Found
No
The 510(k) summary describes a resorbable bone void filler material and its intended use. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The description focuses on the material composition and biological function.
No
The device is described as a bone void filler that resorbs and is replaced by bone during the healing process, indicating it aids in the repair of bone defects rather than treating a disease or disorder from a therapeutic standpoint. It fills bony gaps and voids, assisting the body's natural healing process.
No
Explanation: The provided text describes InQu™ as a resorbable bone void filler used to fill bony gaps or voids. It does not mention any diagnostic capabilities, such as identifying, analyzing, or interpreting medical conditions or disease.
No
The device description clearly states that InQu™ is a physical, sterile, granular, synthetic bone void filler composed of specific materials, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- InQu™'s Function: InQu™ is a bone void filler that is implanted directly into the body to help with bone healing. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states it's for filling bony gaps or voids in the skeletal system. This is a surgical procedure, not a laboratory test.
- Device Description: The description details its composition and how it resorbs and is replaced by bone. This is consistent with an implantable medical device.
Therefore, based on the provided information, InQu™ is a medical device used for surgical intervention, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
InQu™ is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQuTM is intended to be gently packed into bony gaps or voids in the skeletal system (extremities and pelvis). These defects may be surgically created or result from traumatic injury to the bone.
Product codes
MQV
Device Description
InQu™ is intended for single patient use only. InQu™ is a sterile, granular, synthetic bone void filler device composed of poly (D, L-lactide-co-glycolide) and hyaluronic acid. It resorbs and is replaced with bone during the healing process. Testing has confirmed InQu™ is biocompatible as a bone void filler device. InQu™ is substantially equivalent to the predicate device in terms of material composition. technological characteristics and bone healing performance in an animal model.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (extremities 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
PolyGraft™ BGS, OsteoBiologics, Inc., K040047
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
Submitter:
ISTO Technologies, Inc.
...
K063359
InQu™
InQu™ InQu™
Traditional 510(k)
Section 5.0 510(k) Summary
| Submitter Name: | ISTO Technologies, Inc. | APR 16 2007 |
|---|---|---|
| Submitter Address: | 1155 Olivette Executive Parkway, Suite 200 | |
| St. Louis, Missouri 63132 | ||
| Contact Person: | Gary Gage | |
| Program Director | ||
| Phone Number: | 314-995-6049 | |
| Fax Number: | 314-995-6025 | |
| Date Prepared: | November 3, 2006 | |
| Device Trade Name: | InQu™ | |
| Device Common Name: | Resorbable bone void filler | |
| Classification Name: | Filler, bone void, calcium salt compound | |
| Classification Number: | 21 CFR 888.3045 | |
| Product Code: | MQV | |
| Predicate Devices: | PolyGraft™ BGS, OsteoBiologics, Inc., K040047 | |
| Statement of | ||
| Intended Use: | InQu™ is a resorbable bone void filler intended to fill bony gaps or | |
| voids that are not intrinsic to the stability of the bony structure. | ||
| InQuTM is intended to be gently packed into bony gaps or voids in the | ||
| skeletal system (extremities and pelvis). These defects may be | ||
| surgically created or result from traumatic injury to the bone. | ||
| Device Description, | ||
| Summary of | ||
| Technological | ||
| Characteristics, and | ||
| Comparison to the | ||
| Predicate Device | InQu™ is intended for single patient use only. InQu™ is a sterile, | |
| granular, synthetic bone void filler device composed of poly (D, L- | ||
| lactide-co-glycolide) and hyaluronic acid. It resorbs and is replaced | ||
| with bone during the healing process. Testing has confirmed InQu™ | ||
| is biocompatible as a bone void filler device. InQu™ is substantially | ||
| equivalent to the predicate device in terms of material composition. | ||
| technological characteristics and bone healing performance in an | ||
| animal model. |
:
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wing. To the left of the symbol, the text "MENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ISTO Technologies c/o Ms. Patsy J. Trisler, J.D., RAC 5600 Wisconsin Ave. #૨૦તે Chevy Chase, MD 20815
APR 1 6 2007
Re: K063359
Trade Name: InQuTM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler devices Regulatory Class: Class II Product Code: MOV Dated: January 29 2007 Received: January 30, 2007
Dear Ms. Trisler:
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.
2
Page 2 – Ms. Pastsy J. Trisler
You must comply with all the Act's requirements, including, but not limited to: registration r od intilet compy + + + + 807); labeling (21 CFR Part 801); good manufacturing practice and ifsing (21 CF Far are of 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.
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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Barbace Buent
Mark N. Melkerson. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name:
InQu™
Indications for Use:
InQu™ is a resorbable bone void filler intended to fill bony gaps or voids that are not intrinsic to the stability of the bony structure. InQu™ is intended to be gently packed into bony gaps or voids in the skeletal system (extremities and pelvis). These defects may be surgically created or result from traumatic injury to the bone.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
barbare buem
Division of General. Restorative, and Neurological Devices
510(k) Number K063359