(85 days)
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Not Found
No
The summary describes a silicone implant for chest augmentation/reconstruction and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as an implant used for augmentation or reconstruction of the male chest, addressing cosmetic and corrective needs rather than active therapeutic treatment.
No
Explanation: The device description and intended use clearly state that the Hanson Pectoralis Implant is used for augmentation and reconstruction, specifically by inserting an implant. There is no mention of it being used to diagnose any condition or disease.
No
The device description clearly states it is a physical implant made from silicone elastomer materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that the Hanson Pectoralis Implant is a physical implant made of silicone that is surgically inserted into the body (under the pectoralis muscle) to augment or reconstruct the chest. It is a medical device used for surgical procedures, not for testing bodily specimens.
The information provided about the device's materials, manufacturing, and intended use for surgical implantation directly contradicts the definition of an IVD.
N/A
Intended Use / Indications for Use
The intended use of the Hanson Pectoralis Implant is augment or reconstruct the male chest by inserting the implant under the pectoralis muscle usually through a transaxillary incision. The proposed device can also be used for the correction of surface defects resulting from congenital anomalies such as depressions secondary to Poland's Syndrome. This product will be delivered non sterile.
Silicone Carving Blocks are to be used for augmenting the chest by placing the implant in the submuscular space via a trans-axillary incision. They can also be used to reconstruct the pectoralis depression of Poland's Syndrome (Congenitally Absent Pectoralis Muscle)
Product codes (comma separated list FDA assigned to the subject device)
MIC
Device Description
The Hanson Pectoralis Implant is made from the same Silicone liquid elastomer materials and manufacturing processes as the predicate device. The physical properties of this device are the same as the predicate device in that the same materials or equivalent materials will be used. These raw materials are the LSR 30 of Applied Silicone and the MED 4211 unrestricted silicone fluid of Nusil Technologies. The durometers or hardness (Shore A) will range from 5 to 30. The appearance is described as clear to slightly opaque. 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. The implants will be packaged in a tyvec pouch and labeled with the size, cataloque number and dimensions. This inner package will be placed into a white thin paper box. This package will contain an outer label. This box 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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
male chest, pectoralis muscle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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
Hanson Medical Inc. 19325 58th PL NE Seattle WA 98155 (425) 481 2185
DEC 2 4 1997
TAB G
1973729
510 (k) Summary
Substantial Equivalence
The Hanson Medical Pectoralis implant is Substantially Equivalent to the Allied Biomedical Pectoralis Implant. The Hanson Pectoralis Implant is made from the same Silicone liquid elastomer materials and manufacturing processes as the predicate device.
Intended Use
The intended use of the Hanson Pectoralis Implant is augment or reconstruct the male chest by inserting the implant under the pectoralis muscle usually through a transaxillary incision. The proposed device can also be used for the correction of surface defects resulting from congenital anomalies such as depressions secondary to Poland's Syndrome. 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.
Physical and Chemical Properties
The physical properties of this device are the same as the predicate device in that the same materials or equivalent materials will be used. These raw materials are the LSR 30 of Applied Silicone and the MED 4211 unrestricted silicone fluid of Nusil Technologies. The durometers or hardness (Shore A) will range from 5 to 30. The appearance is described as clear to slightly opaque. 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 Pectoralis Implants Continued.
Package Description
The implants will be packaged in a tyvec pouch and labeled with the size, cataloque number and dimensions. This inner package will be placed into a white thin paper box. This package will contain an outer label. This box 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.
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2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kathy Richardson Regulatory Affairs HANSON MEDICAL INC. 19325 58th Place N.E. Seattle, Washington 98155
DEC 2 4 1997
Re: K973729 Trade Name: Powerflex Pec Implant Regulatory Class: II Product Code: MIC Dated: September 27, 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. Kaathy 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,
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
4
INTENDED USE FORM
Page 1 of 1
510 (k) Number (if known)
Device Name: Silicone Pectoralis Implant
Indications For Use:
Silicone Carving Blocks are to be used for augmenting the chest by placing the implant in the submuscular space via a trans-axillary incision. They can also be used to reconstruct the pectoralis depression of Poland's Syndrome (Congenitally Absent Pectoralis Muscle)
Concurrence of CDRH, Office of Device Evaluation (ODE) . . . .
Presecription Use
(Per 21 CFR 801.109)
OR
Over The Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
asion of General Restorative Devices
510(k) Nurhber K973729