(48 days)
Not Found
No
The document describes a bone filling material derived from human bone tissue and processed into a putty. There is no mention of any computational or algorithmic components, let alone AI or ML.
Yes
The device is a bone filling material used for augmentation or reconstructive treatment of the alveolar ridge, which includes therapeutic procedures like filling defects after root resection, apicoectomy, cystectomy, extraction sockets, elevation of maxillary sinus floor, and treatment of periodontal defects.
No
This device is a bone filling material used for augmentation or reconstructive treatment, not for diagnosing a condition. Its function is to fill defects and enhance tissue preservation, which is a therapeutic rather than diagnostic purpose.
No
The device is a bone filling material derived from human bone tissue and combined with a carrier, clearly indicating it is a physical material and 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 describes a material for filling bone defects and augmenting bone in the alveolar ridge. This is a therapeutic and reconstructive purpose, not a diagnostic one.
- Device Description: The description details the composition and properties of a bone filling material derived from human bone tissue. It focuses on its osteoconductive and osteoinductive properties, which are relevant to bone regeneration, not diagnosis.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, or tissue) to provide information about a patient's health status, disease, or condition. There is no mention of any diagnostic output or interpretation.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. This device is used in vivo (inside the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
Accell Connexus™ DBM Putty is a bone filling material indicated for augmentation or reconstructive treatment of alveolar ridge. This includes:
- Filling of defects after root resection, apicoectomy and cystectomy -
- Filling of extraction sockets to enhance preservation of the alveolar ridge -
- Elevation of maxillary sinus floor -
- Treatment of periodontal defects -
Product codes (comma separated list FDA assigned to the subject device)
NUN
Device Description
Accell Connexus™ DBM Putty is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier and formulated to a paste or putty-like consistency.
Accell Connexus DBM Putty is osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar ridge, maxillary sinus floor, periodontal
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)
Product safety and effectiveness is adequately supported by the substantial equivalence information, materials data, and animal test results provided in this Premarket Notification.
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
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
IsoTis OrthoBiologics, Inc. Accell Connexus " DBM Putty 510(k) Premarket Notification
KOBO306
February 2006
MAR 2 7 2006
510(k) Summary for IsoTis OrthoBiologics, Inc. Accell Connexus DBM Putty
-
- SPONSOR
IsoTis OrthoBiologics, Inc. 2 Goodyear, Suite B Irvine, CA 92618 U.S.A
- SPONSOR
| Contact Person: | Eliane Schutte |
|---|---|
| Telephone: | +31-(0) 30-2295253 |
| Facsimile: | +31-(0) 30-2280255 |
| Date Prepared: | February 03, 2006 |
2. DEVICE NAME
Proprietary Name: Accell Connexus Demineralized Bone Matrix Puttv Requlation Name: Human Bone Graft Material Regulatory Class: 11 NUN Product Code:
3. PREDICATE DEVICE
DynaGraft II Dental (Demineralized Bone Matrix) [K043573]
4. DEVICE DESCRIPTION
Accell Connexus™ DBM Putty is derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier and formulated to a paste or putty-like consistency.
Accell Connexus DBM Putty is osteoconductive and osteoinductive bone filling material. The osteoinductive potential is demonstrated in athymic mouse model.
ട. Intended Use
Accell Connexus™ DBM Putty is a bone filling material indicated for augmentation or reconstructive treatment of alveolar ridge. This includes:
- Filling of defects after root resection, apicoectomy and cystectomy -
- Filling of extraction sockets to enhance preservation of the alveolar ridge -
- Elevation of maxillary sinus floor -
- Treatment of periodontal defects -
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Accell Connexus DBM Putty is substantially equivalent to DynaGraft II Dental Putty previously cleared by FDA under 510(k) K043573. Both products utilize
1
IsoTis OrthoBiologics, Inc.
Accell Connexus " DBM Putty 510(k) Premarket Notification
February 2006
ground, human donor cortical demineralized bone for the product. Both products utilize an inactive poloxamer reverse phase carrier (RPM) as a containing agent to provide the product's putty-like consistency and handling characteristics. The proposed device and predicate device have the same indications for use, provided sterile and for single patient. The main difference between the two products is that Accell Connexus DBM Putty contains more demineralized bone by weight and volume and less synthetic carrier.
7. Performance data
Product safety and effectiveness is adequately supported by the substantial equivalence information, materials data, and animal test results provided in this Premarket Notification.
2
Image /page/2/Picture/1 description: The image is a logo for the Department of Health and Human Services, USA. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the circle.
MAR 2 7 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Isotis NV Ms. Elaine Schutte Director of Regulatory Affairs Isotis Orthobiologics, Incorporated 2 Goodyear, Suite B Irvine, California 92618
Re: K060306
Trade/Device Name: Accell Connexus Demineralized Bone Matrix Putty Regulation Number: 872.3930 Regulation Name: Bone Graft Material Regulatory Class: II Product Code: NUN Dated: February 6, 2006 Received: February 7, 2006
Dear Ms. Schutte:
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 (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 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.
3
Page-2 Ms. Elaine Schutte
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.
This letter will allow you to continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Clues
Chiu Lin, Ph.D Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
4
February 2006
IsoTis OrthoBiologics, Inc. Accell Connexus™ DBM Putty 510(k) Premarket Notifica
4 INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if Known):
Device Name: Accell Connexus Demineralized Bone Matrix Putty
Indications for Use:
Accell Connexus™ DBM Putty is a bone filling material indicated for augmentation or reconstructive treatment of alveolar ridge. This includes:
- Filling of defects after root resection, apicoectorny and cystectomy -
- Filling of extraction sockets to enhance preservation of the alveolar ridge -
- Elevation of maxillary sinus floor
- Treatment of periodontal defects
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
'Susan Rumps
logy General Hosp
ntal Devices
060306