(24 days)
Not Found
No
The summary describes a synthetic bone graft substitute material and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a bone graft substitute, which acts as a filler and scaffold for bone growth, rather than actively treating a disease or condition.
No
The device is a bone graft substitute, intended to fill bone voids and promote bone growth, not to diagnose conditions.
No
The device description clearly states it is a synthetic hydroxyapatite bone graft substitute, which 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 clearly states that Apaceram™ is a "bone void filler" for surgical or traumatic bone defects. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description focuses on the material composition (hydroxyapatite), physical properties (porosity, shape, size), and its function as an "osteoconductive bone void filler." This aligns with a medical device used in surgery, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue), detecting specific substances, or providing information for diagnosis.
- Anatomical Site: The device is applied directly to the skeletal system, which is a therapeutic intervention.
- Performance Studies: The summary of performance studies refers to "safety, performance and biocompatibility testing," which are typical for implantable or surgically used medical devices, not IVDs.
In summary, Apaceram™ is a medical device used for bone repair and regeneration, not for diagnosing a condition.
N/A
Intended Use / Indications for Use
Apaceram™ Bone Graft Substitute is a synthetic hydroxyapatite provided in several particulate and shaped sizes. It is intended for use as a bone void filler for bony voids, gaps, or defects that are not intrinsic to the stability of the bony structure. Apaceram™ is intended to be placed into bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. It also can be used with autograft as a bone graft extender. Apaceram™ is resorbed and replaced with bone during the healing process.
Product codes
MQV
Device Description
Apaceram™ Bone Graft Substitute is a synthetic hydroxyapatite provided in several particulate and shaped sizes. It is intended for use as a bone void filler for bony voids, gaps, or defects that are not intrinsic to the stability of the bony structure. Apaceram™ is intended to be placed into bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. It also can be used with autograft as a bone graft extender. Apaceram™ is resorbed and replaced with bone during the healing process.
Apaceram™ is a hydroxyapatite osteoconductive bone void filler. It is available in four types: AX, B, G, and R, which vary in porosity, shape and sizes. Apaceram™ is provided sterile for single patient use.
Apaceram™ is composed of calcium salts, is osteoconductive, and provides an interconnected, highly porous scaffold environment for new bone ingrowth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e. extremities, posterolateral spine, or 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)
The safety, performance and biocompatibility testing were submitted in the original Apaceram™ 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K071912 Apaceram™ Bone Graft Substitute, Pentax Corp.
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
KI20602
MAR 2 3 2012
Submitter: HOYA Corporatio
Apaceram™ Special 510(k)
, Haga-
| HOYA Corporation PENTAX New Ceramics Division | |
|---|---|
| 510(k) SUMMARY | |
| Apaceram™ Bone Void Filler | |
| Submitter Name: | HOYA Corporation PENTAX New Ceramics Division |
| Submitter Address: | 2-7-5 Naka-Ochiai, Shinjuku-ku, Tokyo 161-8525 JAPAN |
| Contact Person: | Manufacturing Site: |
| PENTAX Mashiko Factory: 858 Hanawa, Mashiko-machi, H | |
| gun, Tochigi 321-4292 Japan | |
| Nobuyuki Asaoka |
International Sales Group
New Ceramics Division |
| Phone Number: | 813-5840-6141 |
| Fax Number: | 813-5840-6143 |
| Date Prepared: | February 27, 2012 |
| Device Trade Name: | Apaceram™ Bone Graft Substitute |
| Device Common Name: | Synthetic, porous hydroxylapatite |
| Classification Number: | 21 CFR 888.3045 |
| Classification Name: | Resorbable calcium salt bone void filler |
| Product Code: | MQV |
| Predicate Devices: | K071912 Apaceram™ Bone Graft Substitute, Pentax Corp. |
Apaceram™ Bone Graft Substitute is a synthetic hydroxyapatite provided in several particulate and shaped sizes. It is intended for use as a bone void filler for bony voids, gaps, or defects that are not intrinsic to the stability of the bony structure. Apaceram™ is intended to be placed into bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. It also can be used with autograft as a bone graft extender. Apaceram™ is resorbed and replaced with bone during the healing process.
Apaceram™ is a hydroxyapatite osteoconductive bone void filler. It is available in four types: AX, B, G, and R, which vary in porosity, shape and sizes. Apaceram™ is provided sterile for single patient use.
Apaceram™ is composed of calcium salts, is osteoconductive, and provides an interconnected, highly porous scaffold environment for new bone ingrowth. The safety, performance and biocompatibility testing were submitted in the original Apaceram™ 510(k).
The Apaceram™ Bone Graft Substitute is identical to the predicate device. The purpose of this 510(k) is to reflect the change in ownership of Apaceram™ from Pentax Corporation to HOYA Corporation PENTAX New Ceramics Division.
Statement of Intended Use:
Device Description:
Technological Characteristics and Testing:
Substantial Equivalence:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird in flight, with three curved lines representing its wings and body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Hova Corporation PENTAX New Ceramics Division % Trisler Consulting Patsy J. Trisler, JD, RAC 5600 Wisconsin Avenue, #509 Chevy Chase, Maryland 20815
MAR 2 3 2012
Re: K120602
Trade/Device Name: Apaceram™ Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV Dated: February 27, 2012 Received: February 28, 2012
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. 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.
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.
2
Page 2 - Patsy J. Trisler, JD, RAC
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you desire specific advice to: JDA/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 note the 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 Tou may 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/ResourcesforYou/Industry/default.htm
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
10 /1
Enclosure
3
Submitter: Hoya Corporation Pentax New Ceramics Division
Apaceram™ Special 510(k)
510(k) Number (if known):
Device Name:
Apaceram™ Bone Graft Substitute
Indications for Use:
Apaceram™ Bone Graft Substitute is a synthetic hydroxyapatite provided in several particulate and shaped sizes. It is intended for use as a bone void filler for bony voids, gaps, or defects that are not intrinsic to the stability of the bony structure. Apaceram™ is intended to be placed into bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. It also can be used with autograft as a bone graft . extender. Apaceram™ is resorbed and replaced with bone during the healing process.
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)
Knutsen N. Loria
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120602
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