(274 days)
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.
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.
This response will address the request based on the provided text, but it's important to note that the document (a 510(k) summary) does not contain the specific types of studies (e.g., MRMC, standalone algorithm performance, detailed ground truth establishment for a diagnostic device) typically associated with establishing acceptance criteria for diagnostic or AI-driven medical devices.
The provided document describes a bone filling augmentation material (NanoGen), not a diagnostic device or an AI-powered system that requires performance metrics like sensitivity, specificity, or AUC against a ground truth established by experts. Instead, the "acceptance criteria" for this type of device are primarily related to substantial equivalence to existing predicate devices, focusing on material composition, intended use, physical properties (resorption time), and adherence to recognized standards. The "study" mentioned is primarily a summary of testing related to chemical composition and biocompatibility, along with a literature review.
Therefore, the answers will reflect the nature of the provided document for a bone graft material, rather than a diagnostic AI device.
Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria (for NanoGen - Bone Filling Augmentation Material)
The acceptance criteria for NanoGen are implicitly defined by its demonstration of substantial equivalence to predicate devices (SurgiPlaster K011403 and BoneGen-TR K060285) based on intended use, material composition, physical properties, and adherence to recognized standards. The "study" that proves the device meets these criteria is a combination of chemical testing, literature review, and comparison with predicate devices.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (NanoGen) |
|---|---|
| Intended Use Equivalence | |
| 1. Use by itself in bone regeneration | Same |
| 2. Mixed with other bone grafts | Same |
| 3. Providing a resorbable barrier | Same |
| Material Composition Equivalence | |
| Primarily Calcium Sulfate | Mixture of nanocrystalline calcium sulfate particles and medical grade calcium sulfate hemihydrate powder. (Tested for chemical composition) |
| Physical Properties (Resorption Time) | |
| Resorption in a specific timeframe | Completely resorbs in 10-12 weeks (In vitro dissolution studies confirmed degradation in 12 weeks; confirmed by in vivo studies). |
| Adherence to Recognized Standards | |
| ASTM F2224-03 for properties of calcium sulfate | Compliant (Listed as an FDA-Recognized Standard) |
| 510(k) Sterility Review Guidance K90-1 | Compliant (Listed as an FDA-Recognized Standard) |
| ISO 11137-1:2006 (for Sterilization) | Compliant (Listed as an FDA-Recognized Standard) |
| Biocompatibility and Safety | Qualified as biocompatible and safe for intended use based on chemical testing by an independent laboratory (USP NSF 18) and extensive literature review. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the context of a diagnostic or AI device for which performance metrics (e.g., sensitivity, specificity) are calculated. Instead, the "testing" focused on material characteristics:
- Chemical Composition Testing: The chemical composition of the Calcium Sulfate Hemihydrate used to make NanoGen was tested by an independent laboratory. No specific sample size for this chemical test is provided, but it would typically involve a representative sample of the raw material. The provenance is implied to be from the independent laboratory conducting the test.
- In vitro Dissolution Studies: These studies confirmed NanoGen's degradation time. No specific sample size or provenance is detailed, but these are typically laboratory-controlled experiments.
- In vivo studies: The document states that "This finding [12-week degradation] has been confirmed by in vivo studies." No details on sample size, animal model, or human subjects are provided within this summary.
- Literature Review: Extensive literature articles documenting the use of calcium sulfate particles were provided to support biocompatibility and safety. This is a review of existing, published data rather than new prospective or retrospective data generated for this specific submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the type of device (bone filling augmentation material) and the nature of the provided 510(k) summary. There was no "ground truth" to be established by clinical experts in the context of diagnostic accuracy. The assessment focuses on material properties, safety, and equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There was no "test set" requiring adjudication by multiple experts in the context of diagnostic agreement.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. This device is a bone filling augmentation material, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a physical biomaterial, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device relates to its material properties and biological interactions, assessed through:
- Chemical analysis: Conformance to recognized standards for calcium sulfate.
- In vitro and in vivo degradation: Observational data on resorption time.
- Biocompatibility: Established through literature review and material testing.
This is fundamentally different from a ground truth for a diagnostic device (e.g., pathology report for a cancer diagnosis).
8. The sample size for the training set
This information is not applicable. This device is a physical biomaterial and does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated in point 8.
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SECTION 1
510 (K) SUMMARY
Submitted by:
| Company Name: | Orthogen LLC |
|---|---|
| Address: | 505 Morris Avenue, Ste 104Springfield, 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.
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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 boneregeneration2. Mixed with otherbone grafts3. Providing aresorbable barrierover other bonegrafts | 1. By itself in boneregeneration2. Mixed with other bonegrafts3. Providing a resorbablebarrier over other bonegrafts |
| Device Design | 0.65 grams medical gradecalcium sulfate particles400 - 850 microns in sizemixed with 0.35 gramsmedical grade calciumsulfate powder; regular setsolution (saline) provided | Medical grade calcium sulfatehemihydrate powder, suppliedwith regular set (saline) and fastset (potassium sulfate) liquids |
| Composition ofMaterials | Medical grade calciumsulfate, normal saline(Regular Set) | Medical grade calcium sulfate,normal saline (Regular Set) and4% Potassium sulfate solution(Fast Set) |
| Physical Properties | Completely resorbs in 10-12 weeks, mix of powderand particles | Resorbs in 4-6 weeks, providedin powder form |
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510(k) Summary-Continued
| FDA-RecognizedStandards | ASTM F2224-03 forproperties of calciumsulfate510(k) Sterility Review | ASTM F04.13.15 for propertiesof calcium sulfateEN 552, 554 and 556 forsterilization standard |
|---|---|---|
| Guidance K90-1ISO 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 regeneration2. Mixed with other bone grafts3. Providing a resorbable barrier over other bone grafts | 1. Oral Surgery: Post-extraction2. Periodontics: Infra-osseous defects.3. Endodontics: Apicoectomy, Root perforations, Open apices.4. 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 |
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510(k) Summary-Continued
| Physical Properties | Completely resorbs in 10-12weeks, mix of powder andparticles | Completely resorbs in 16 weeks,particle size range is 425 to 850micron |
|---|---|---|
| FDA-RecognizedStandards | ASTM F2224-03 forproperties of calcium sulfate510(k) Sterility ReviewGuidance K90-1ISO 11137-1:2006 | ASTM F2224-03 for properties ofcalcium sulfateANSI/AAMI/ISO standard11737-1995 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.
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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.
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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
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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
§ 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.