(274 days)
K 011403, K060285
Not Found
No
The summary describes a material composition and its physical properties, with no mention of AI/ML or data processing capabilities.
Yes
NanoGen is used in bone regenerative techniques, which directly addresses a medical condition (bone defects) and promotes healing and restoration, fitting the definition of a therapeutic device.
No
NanoGen is described as a material used in bone regenerative techniques, either alone or mixed with other bone filling agents, to provide a resorbable barrier and contribute to bone mineralization. Its function is to facilitate biological processes, not to diagnose medical conditions or diseases.
No
The device description clearly states that NanoGen is a mixture of physical particles (calcium sulfate) and is applied as a paste, indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of NanoGen is for bone regenerative techniques, acting as a bone filling agent and a resorbable barrier. This is a therapeutic and structural application within the body.
- Device Description: The description details the composition and function of the material within the bone defect.
- Lack of Diagnostic Function: There is no mention of NanoGen being used to test a sample from the human body to provide information about a physiological state, disease, or condition. IVDs are used in vitro (outside the body) to analyze samples like blood, urine, or tissue.
NanoGen is a medical device used for surgical and regenerative purposes, not for diagnostic testing.
N/A
Intended Use / Indications for Use
NanoGen is indicated for use in the following ways; by itself in bone regenerative techniques; mixed with other suitable bone filling agents to prevent particle migration in an osseous defect; and, to provide a resorbable barrier over other bone graft materials.
Product codes (comma separated list FDA assigned to the subject device)
LYC
Device Description
NanoGen is a mixture of particles composed of densely packed grains of nanocrystalline calcium sulfate and medical grade calcium sulfate hemihydrate powder. The particles range from 400 - 850 microns in size. The particles of nanocrystalline calcium sulfate are purely synthetic and are manufactured from medical grade calcium sulfate hemihydrate through a proprietary process. Because of its unique structure, NanoGen undergoes controlled, slower degradation as compared to traditional calcium sulfate.
NanoGen is designed to set-up in vivo and may be used either alone or mixed with DFDBA (demineralized freeze-dried bone allograft) or autogenous bone in bone in bone regenerative procedures. It is mixed with small amounts of normal saline to produce a putty-like paste and is then applied to the bone defects. Set NanoGen dissolves with time. The calcium present in NanoGen is believed to contribute to the mineralization of newly regenerated bone. In vitro dissolution studies conducted by incubating NanoGen particles in simulated body fluid confirmed that NanoGen undergoes degradation in 12 weeks as opposed to the 4 - 6 week degradation time found for medical grade calcium sulfate powder. This finding has been confirmed by in vivo studies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Orthogen LLC has 1) tested the chemical composition of Calcium Sulfate Hemihydrate used to make NanoGen by an independent laboratory to a recognized test method (USP NSF 18) and reported the results in this submission; and, 2) has provided extensive literature articles documenting the use of calcium sulfate particles as a bone augmentation material. Therefore this material has been qualified as biocompatible and safe for its intended use. This device is not marketed as non-pyrogenic.
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.
K 011403, K060285
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
SECTION 1
510 (K) SUMMARY
Submitted by:
| Company Name: | Orthogen LLC |
|---|---|
| Address: | 505 Morris Avenue, Ste 104 |
| Springfield, NJ 07081 | |
| Telephone: | 973-467-2404 |
| Fax: | 973-467-1218 |
CONTACT PERSON:
Harold Alexander, Ph.D. 505 Morris Avenue, Suite 104 Springfield, NJ, 07081 Ph: 973-467-2404 Fax: 973-467-1218 Email : halexander(@orthogencorp.com
DATE PREPARED:
08/03/2010
TRADE NAME:
NanoGen (Nanocrystalline calcium sulfate particles)
COMMON NAME: Bone filling augmentation material
SUBSTANTIALLY EQUIVALENT TO:
SurgiPlaster K 011403, BoneGen-TR K 060285
DESCRIPTION of the DEVICE: NanoGen is a mixture of particles composed of densely packed grains of nanocrystalline calcium sulfate and medical grade calcium sulfate hemihydrate powder. The particles range from 400 - 850 microns in size. The particles of nanocrystalline calcium sulfate are purely synthetic and are manufactured from medical grade calcium sulfate hemihydrate through a proprietary process. Because of its unique structure, NanoGen undergoes controlled, slower degradation as compared to traditional calcium sulfate.
NanoGen is designed to set-up in vivo and may be used either alone or mixed with DFDBA (demineralized freeze-dried bone allograft) or autogenous bone in bone in bone regenerative procedures. It is mixed with small amounts of normal saline to produce a putty-like paste and is then applied to the bone defects. Set NanoGen dissolves with time. The calcium present in NanoGen is believed to contribute to the mineralization of newly regenerated bone. In vitro dissolution studies conducted by incubating NanoGen particles in simulated body fluid confirmed that NanoGen undergoes degradation in 12 weeks as opposed to the 4 - 6 week degradation time found for medical grade calcium sulfate powder. This finding has been confirmed by in vivo studies.
1
510(k) Summary-Continued
INDICATIONS FOR USE:
NanoGen is indicated for use in the following ways; by itself in bone regenerative techniques; mixed with other suitable bone filling agents to prevent particle migration in an osseous defect; and, to provide a resorbable barrier over other bone graft materials.
COMPARISON WITH PREDICATE DEVICES:
1. Comparison of NanoGen and SurgiPlaster:
NanoGen is substantially equivalent to:
SurgiPlaster Calcium Sulfate hemihydrate Bone Graft Plaster K011403
Equivalency is determined by:
- NanoGen has the same indication for use and labeling claims. >
- √ NanoGen has similar material composition.
| Device Description | Device (NanoGen) | Predicate (SurgiPlaster) |
|---|---|---|
| Intended Use | 1. By itself in bone | |
| regeneration |
- Mixed with other
bone grafts - Providing a
resorbable barrier
over other bone
grafts | 1. By itself in bone
regeneration - Mixed with other bone
grafts - Providing a resorbable
barrier over other bone
grafts |
| Device Design | 0.65 grams medical grade
calcium sulfate particles
400 - 850 microns in size
mixed with 0.35 grams
medical grade calcium
sulfate powder; regular set
solution (saline) provided | Medical grade calcium sulfate
hemihydrate powder, supplied
with regular set (saline) and fast
set (potassium sulfate) liquids |
| Composition of
Materials | Medical grade calcium
sulfate, normal saline
(Regular Set) | Medical grade calcium sulfate,
normal saline (Regular Set) and
4% Potassium sulfate solution
(Fast Set) |
| Physical Properties | Completely resorbs in 10-
12 weeks, mix of powder
and particles | Resorbs in 4-6 weeks, provided
in powder form |
2
510(k) Summary-Continued
| FDA-Recognized
Standards | ASTM F2224-03 for
properties of calcium
sulfate
510(k) Sterility Review | ASTM F04.13.15 for properties
of calcium sulfate
EN 552, 554 and 556 for
sterilization standard |
|-----------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| | Guidance K90-1
ISO 11137-1:2006 | |
2. Comparison of NanoGen and BoneGen - TR:
NanoGen is substantially equivalent to:
BoneGen-TR K060285
Equivalency is determined by:
- √ NanoGen has the same indication for use and labeling claims.
- ✔ NanoGen is manufactured using same technology.
- √ NanoGen is sterilized in the same manner.
| Device Description | Device (NanoGen) | Device (BoneGen – TR) |
|---|---|---|
| Intended Use | 1. By itself in bone regeneration |
- Mixed with other bone grafts
- Providing a resorbable barrier over other bone grafts | 1. Oral Surgery: Post-extraction
- Periodontics: Infra-osseous defects.
- Endodontics: Apicoectomy, Root perforations, Open apices.
- Implantology: Dehiscences, fenestrations, sinus lifts. |
| Device Design | 0.65 grams of medical grade calcium sulfate particles 400-850 microns in size mixed with 0.35 grams of medical grade calcium sulfate powder; regular set solution (saline) also provided. | Composite particles (425-850 micron) of medical grade calcium sulfate and PLLA (ratio of 96:4) supplied in 1.5 gram packs |
| Composition of Materials | Medical grade calcium sulfate, normal saline (Regular Set) | Medical grade calcium sulfate and PLLA |
3
510(k) Summary-Continued
| Physical Properties | Completely resorbs in 10-12
weeks, mix of powder and
particles | Completely resorbs in 16 weeks,
particle size range is 425 to 850
micron |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| FDA-Recognized
Standards | ASTM F2224-03 for
properties of calcium sulfate
510(k) Sterility Review
Guidance K90-1
ISO 11137-1:2006 | ASTM F2224-03 for properties of
calcium sulfate
ANSI/AAMI/ISO standard
11737-1995 for sterilization |
SUMMARY of TESTING:
Orthogen LLC has 1) tested the chemical composition of Calcium Sulfate Hemihydrate used to make NanoGen by an independent laboratory to a recognized test method (USP NSF 18) and reported the results in this submission; and, 2) has provided extensive literature articles documenting the use of calcium sulfate particles as a bone augmentation material. Therefore this material has been qualified as biocompatible and safe for its intended use. This device is not marketed as non-pyrogenic.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing strokes, representing service to the people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 6 2011
Harlod Alexander, Ph.D. Chief Executive Officer Orthogen, LLC 505 Morris Avenue, Suite 104 Springfield, New Jersey 07081-1033
Re: K102208
Trade/Device Name: NanoGen (nanocrystanlline Calcium Sulfate Particles) Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: April 26, 2011 Received: April 27, 2011
Dear Dr. Alexander:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
5
Page 2- Mr. Alexander
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number K102208
Device Name: NanoGen (nanocrystalline calcium sulfate particles)
Indications For Use:
-
- By itself in bone regenerative techniques;
-
- Mixed with other suitable bone filling agents to prevent particle migration in an osseous defect; and,
-
- To provide a resorbable barrier over other bone graft materials.
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)
Rent P.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Susta
510(k) Number: K102208