(9 days)
Not Found
No
The device description and performance studies focus on the biological properties and processing of demineralized bone matrix and a biocompatible carrier. There is no mention of AI or ML technology being used in the device's function, manufacturing, or analysis.
Yes
The device is described as treating "oralmaxillofacial and dental intraosseous defects" and uses human demineralized bone matrix to aid in bone formation and healing, which are therapeutic actions.
No
Explanation: The device, PROGENIX® DBM Putty and PROGENIX® Plus, is described as a material intended for the augmentation and treatment of bone defects, such as ridge augmentation or filling of cystic defects. It is a regenerative medicine product ("human demineralized bone matrix") used in surgical procedures, specifically designed to be osteoinductive and osteoconductive for bone healing. It does not perform any diagnostic function.
No
The device description clearly states that PROGENIX® contains human demineralized bone matrix (DBM) in a biocompatible carrier, 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 describes the device as being used for the augmentation and treatment of bone defects in the oralmaxillofacial region. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details the composition of the device (human demineralized bone matrix, carrier) and its physical properties (flowable, moldable). It also mentions its osteoinductive and osteoconductive properties, which relate to bone growth and healing. These are characteristics of a therapeutic device.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue) to provide information about a disease or condition. IVDs are designed for this purpose.
- Performance Studies: The performance studies described focus on osteoinductivity and viral inactivation, which are relevant to the safety and efficacy of a bone graft material, not a diagnostic test.
In summary, the device is a therapeutic product used for bone grafting and repair, not a diagnostic tool used to analyze samples for medical information.
N/A
Intended Use / Indications for Use
PROGENIX® DBM Putty and PROGENIX® Plus are intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects including but not limited to:
Ridge augmentation
Filling of cystic defect
Filling of extraction sites
Filling of lesions of periodontal origin
Craniofacial augmentation
Filling of defects of endodontic origin
Mandibular reconstruction
Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture
Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.
Product codes (comma separated list FDA assigned to the subject device)
NUN
Device Description
PROGENIX® contains human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. PROGENIX® is available in two forms: Putty and Plus. The PROGENIX® Plus version contains two different sized demineralized bone particles.
PROGENIX® DBM Putty and PROGENIX® Plus are single use products intended for use in the oralmaxillofacial region. Additionally, these products are not designed to impart any mechanical strength to the surgical site. Both versions are provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. These products have been shown to be osteoinductive in an athymic rat assay, as well as osteoconductive, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing.
The purpose of this Special 510(k): Device Modification application is to include a new formulation (PROGENIX® Plus) to the previously cleared PROGENIX® product line. The subject device, like the predicate device, contains human demineralized bone matrix (DBM) in a biocompatible carrier, however PROGENIX® Plus will also contain two different sized demineralized bone particles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oralmaxillofacial region, maxillary and mandibular alveolar ridges
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)
All DBM used in the preparation of PROGENIX® Plus must induce bone formation when evaluated in a validated athymic nude rat assay. Additionally, PROGENIX® must also induce bone formation in this assay system prior to being released for use. The raw material and final product screening must show histologic evidence of osteoinduction through the presence of osteoblasts, chrondoblasts and/or woven bone. Osteoinduction assay results using the athymic rat assay should not be interpreted to predict clinical performance in human subjects.
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.
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Medtronic Sofamor Danek PROGENIX® Plus 510(k) Summary June 2008
'JUL 1 8 2008
- Medtronic Sofamor Danek USA l. Company: 1800 Pyramid Place Memphis, TN 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738
- Ryan Massey Contact: Regulatory Affairs Specialist
- PROGENIX® Plus ll. Proposed Proprietary Trade Name: Resorbable calcium salt bone Classification Name: void filler device NUN Product Code: Regulation No .: 872.3930
Product Description/Purpose of Application ���.
PROGENIX® contains human demineralized bone matrix (DBM) in a biocompatible carrier. The carrier is a mixture of bovine collagen with a natural polysaccharide (sodium alginate). The components are mixed in phosphate buffered saline to achieve a flowable or moldable consistency. PROGENIX® is available in two forms: Putty and Plus. The PROGENIX® Plus version contains two different sized demineralized bone particles.
PROGENIX® DBM Putty and PROGENIX® Plus are single use products intended for use in the oralmaxillofacial region. Additionally, these products are not designed to impart any mechanical strength to the surgical site. Both versions are provided in ready-to-use malleable forms that may be molded or manipulated by the surgeon into various shapes. These products have been shown to be osteoinductive in an athymic rat assay, as well as osteoconductive, allowing for bony ingrowth across the graft site while resorbing at a rate consistent with bony healing.
1
The purpose of this Special 510(k): Device Modification application is to include a new formulation (PROGENIX® Plus) to the previously cleared PROGENIX® product line. The subject device, like the predicate device, contains human demineralized bone matrix (DBM) in a biocompatible carrier, however PROGENIX® Plus will also contain two different sized demineralized bone particles. The indications for PROGENIX® Plus will be identical to the previously cleared PROGENIX® product (K080462, SE 05/13/08).
IV. Indications
PROGENIX® DBM Putty and PROGENIX® Plus are intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects including but not limited to:
Ridge augmentation Filling of cystic defect Filling of extraction sites Filling of lesions of periodontal origin Craniofacial augmentation Filling of defects of endodontic origin Mandibular reconstruction Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.
V. Substantial Equivalence
Documentation is provided that demonstrates PROGENIX® Plus is substantially equivalent to previously cleared bone void fillers such as PROGENIX® DBM
1081950
2
Putty (Medtronic Sofamor Danek, K080462, SE 05/13/08) and GRAFTON® DBM Crunch (Osteotech Inc., K051188, SE 01/03/06).
Osteoinductivity Potential VI.
All DBM used in the preparation of PROGENIX® Plus must induce bone formation when evaluated in a validated athymic nude rat assay. Additionally, PROGENIX® must also induce bone formation in this assay system prior to being released for use. The raw material and final product screening must show histologic evidence of osteoinduction through the presence of osteoblasts, chrondoblasts and/or woven bone. Osteoinduction assay results using the athymic rat assay should not be interpreted to predict clinical performance in human subjects.
VIII. Viral Inactivation
PROGENIX® Plus is produced from tissue and collagen that undergoes processing steps validated to inactivate a panel of viruses representative of those that are clinically relevant. The cortical bone used to produce the DBM undergoes a proprietary process demonstrated to inactivate viruses. Furthermore, the DBM undergoes additional steps that are also effective at inactivating viruses. The viral inactivation testing demonstrates suitable viral inactivation potential of the processing methods for a wide range of potential human viruses. These processing steps further reduce the risk of viral contamination beyond donor screening and testing.
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Image /page/3/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ryan Massey Regulatory Affairs Specialist Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, Tennessee 38132
[JUL 1 8 2008
Re: K081950 Trade/Device Name: PROGENIX® Plus Regulation Number. 21CFR 872.3936 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NUN Dated: July 3, 2008 Received: July 9, 2008
Dear Mr. Massey:
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.
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Page 2 - Mr. Massey
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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suze Puns
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
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K 081950
510(k) Number (if known):
PROGENIX® Plus Device Name:
Indications for Use:
PROGENIX® DBM Putty and PROGENIX® Plus are intended for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oralmaxillofacial and dental intraosseous defects including but not limited to:
Ridge augmentation
Filling of cystic defect
Filling of extraction sites
Filling of lesions of periodontal origin
Craniofacial augmentation
Filling of defects of endodontic origin
Mandibular reconstruction
Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture
Filling of resection defects in benign bone tumors, benign cysts or other osseous defects in the alveolar ridge wall.
Prescription Use X (Part 21 CFR 801 Subpart 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)
Susan Rioner
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _