(44 days)
Not Found
Not Found
No
The device description focuses solely on the physical properties and materials of silicone carving blocks, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device itself is a carving block used by surgeons to create implants or bone onlays, not a device used to treat or cure a disease or condition directly.
No
This device is described as "Silicone Carving Blocks" used for "carving implants or bone onlays for various surgical uses by the surgeon." It is used to manufacture or shape medical devices, not to diagnose medical conditions.
No
The device description clearly states it is a physical silicone carving block made from specific materials and manufacturing processes, intended for carving implants or bone onlays. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for carving implants or bone onlays for surgical use by a surgeon. This is a surgical tool used in vivo (within the body) or for preparing devices to be used in vivo.
- Device Description: The description details the material and physical properties of a silicone block used for carving. It does not describe a device used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic testing.
Therefore, this device falls under the category of a surgical tool or material used for creating implants, not an IVD.
N/A
Intended Use / Indications for Use
The intended use of the Hanson Carving block is for carving a finished device by the surgeon for his own custom use. The square or rectangular blocks are designed for carving flatter devices for or recearing broom arrection of surface defects resulting from skeletal anomalies such as depressions secondary to trauma or cancer resection. The curved blocks are generally used for carving curved devices such as malar and chin implants. This product will be delivered non sterile.
Silicone Carving Blocks are to be used for carving implants or bone onlays for various surgical uses by the surgeon. The contour carving blocks with curved surfaces lend themselves to carving chin and malar implants.
Product codes (comma separated list FDA assigned to the subject device)
MIB
Device Description
The Hanson Medical Carving block is made from silicone carving materials. The durometers or hardness (Shore A) will range from 5 to 60. The appearance is described as clear to slightly opaque. Pigments will be added such as Iron Oxide and Titanium Oxide to create opacity to light and Radiographic exam. The raw materials for these blocks will be Applied Silicone's LSR series and Nusil Unrestricted MED 4211. Tensile strength from lot to lot average 600 PSI or greater. The percent elongation is over 400 percent. The Chemical components of this device are polysiloxanes catalyzed by a two part system. The blocks will be packaged in a tyvec pouch and labeled with the dimensions. This inner package will be placed into a white thin paper box, which will contain an insert. The package will be properly cushioned with bubble wrap and shipped in a corrugated box.
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
surgeon
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)
Not Found
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.
The Hanson redrear Carving Block, the Allied Biomedical Contour Arred Block
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
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.
0
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长973728
Hanson Medical Inc. 19325 58th PL NE Seattle WA 98155 (425) 481 2185
NOV 1 3 1997
TAB G
510 (k) Summary
Substantial Equivalence
The Hanson Medical Carving block is Substantially Equivalent to the The Hanson redrear Carving Block and the Allied Biomedical Contour Arred Block. The Hanson Blocks is made from the same Silicone carving broom materials and manufacturing processes as the predicate device.
Intended Use
The intended use of the Hanson Carving block is for carving a finished device by the surgeon for his own custom use. The square or rectangular blocks are designed for carving flatter devices for or recearing broom arrection of surface defects resulting from skeletal anomalies such as depressions secondary to trauma or cancer resection. The curved blocks are generally used for carving curved devices such as malar and chin implants. This product will be delivered non sterile.
Labeling
The labeling for this device will comprise a label for the inner package and a label for the outer box. Catalog numbers and sizes will be depicted on the labels. The package insert will contain instructions for use and sterilization. Product promotional literature will merely depict the sizes shapes and material hardness with minimal claims.
Physical and Chemical Properties
The physical properties of these devices are the same as the predicate device in that the same materials will be used. The durometers or hardness (Shore A) will range from 5 to 60. The appearance is described as clear to slightly opaque. Pigments will be added such as Iron Oxide and Titanium Oxide to create opacity to light and Radiographic exam. The raw materials for these blocks will be Applied Silicone's LSR series and Nusil Unrestricted MED 4211. Tensile strength from lot to lot average 600 PSI or greater. The percent elongation is over 400 percent. Each lot is certified and tested for compliance to the parameters set for in the raw material certifications for each lot tested by the manufacturer. The Chemical components of this device are polysiloxanes catalyzed by a two part system. Refer to master files MAF 562 of Applied and MAF 612 of Nusil for complete material characterizations.
1
510(k) Summary Carving Blocks Continued.
Package Description
The blocks will be packaged in a tyvec pouch and labeled with the fic brocks wirr be pashaged in a limensions. This inner package will be placed into a white thin paper box. This package will contain an praced theo a will be properly cushion with bubble wrap and shipped in a corrugated box. Package inserts will be placed into the inner box and a packing slip will be placed in the shipping box.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is a stylized image of three faces in profile, stacked on top of each other, with a wavy line below them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 1997
Ms. Kathy Richardson Regulatory Affairs Hanson Medical Inc. 19325 58th Place NE Seattle, Washington 98155
Re: K973728 Trade Name: Silicone Carving Block Regulatory Class: Unclassified Product Code: MIB Dated: September 18, 1997 Received: September 30, 1997
Dear Ms. Richardson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Kathy Richardson
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
picseep
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number(if known)_K973728
Device Name: Silicone Carving Block
Indications For Use:
Silicone Carving Blocks are to be used for carving implants or bone
s and and survives are to be the surgeon. The contour Silicone Carving Blocks are Lo be used for earmy an. The contour
onlays for various surgical uses by the surgen. The contour onlays for various surgical uses by che bargest.
carving blocks with curved surfaces lend themselves to carving chin
carving blocks with alrets carving brook malar implants.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) Division of General Restorative Devices | |
|---|---|
| 510(k) Number | K973728 |
| Presecription Use | X |
|---|---|
| ------------------- | --- |
OR
| Over The Counter Use | |
|---|---|
| -- | ---------------------- |