(84 days)
DEN 150055
Not Found
No
The device description and performance studies focus on mechanical, material, and software functionality related to controlled gas release for tissue expansion, with no mention of AI or ML.
Yes
The device is used for soft tissue expansion in breast reconstruction following mastectomy, for the treatment of underdeveloped breasts, and for the treatment of soft tissue deformities in the breast, all of which are considered therapeutic applications.
No
The device is a tissue expander used for breast reconstruction and soft tissue deformities, which is a therapeutic device, not a diagnostic one. It does not identify or characterize a disease or condition.
No
The device description explicitly states the system is comprised of a sterile, implantable tissue expander, a remote control (Controller), and a Master Key, which are hardware components. While software testing is mentioned, it is part of a system that includes physical devices.
Based on the provided information, the AeroForm® Tissue Expander System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for soft tissue expansion in breast reconstruction and treatment of breast deformities. This is a surgical/implantable procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a sterile, implantable tissue expander that uses compressed CO2 gas to expand tissue. This is a physical device used for a therapeutic purpose (tissue expansion), not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The AeroForm® Tissue Expander System does not fit this definition.
N/A
Intended Use / Indications for Use
The AeroForm® Tissue Expander System is used for soft tissue expansion in breast reconstruction following mastectorny. for the treatment of underdeveloped breasts, and for the treatment of soft tissue deformities in the breast.
The AeroForm® Tissue Expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond 6 months.
Product codes (comma separated list FDA assigned to the subject device)
PON, PQN
Device Description
The AeroForm Tissue Expander System (AeroForm System) is a sterile temporary implant for breast reconstruction and is comprised of a sterile, implantable tissue expander), a remote control (Controller), and a Master Key. The AeroForm Tissue Expander is a comprised of an outer textured silicone shell, an inner gas barrier (bag), with an internal reservoir of compressed Carbon Dioxide (CO2) gas, which is released within the Expander by using the remote control (Controller), resulting in gradual expansion of the Expander. In a typical, twostage breast reconstruction, a tissue expander device is placed under the pectoralis major muscle and remaining skin following a mastectomy procedure. The Expander is gradually expanded over time through the release of carbon dioxide, causing the overlying skin and muscle to stretch. When adequate tissue coverage is achieved, the expansion device is removed and replaced with a breast implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breast
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)
Mechanical Performance Testing: Performance testing for the Expander included extensive evaluation of the device through performance and functional testing as described in ASTM F1441, Standard Specification for Soft Tissue Expanders. The following mechanical tests were performed: Endurance / Stress Tests (cycle, impact, elongation, and sustained pressure), Break Force, Fused or Adhered Joint Testing, Overexpansion. All mechanical performance testing results met their pre-determined acceptance criteria and the requirements of ASTM standard for tissue expanders, demonstrating that the proposed device is substantially equivalent to the predicate device.
Sterilization and Package Integrity Testing: Sterilization validation, package integrity and shelf-life testing were performed, per applicable standards, demonstrating the package remains intact following climactic conditioning, gross leak, and seal strength testing.
Software Testing: Unit, System and Regression Testing was performed, as described in Software test plans and testing protocols. Software development is compliant with EN 62304, and applicable US FDA guidance documents.
Biocompatibility: The Expander was tested for biological safety according to the requirements of EN ISO 10993-1: "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing. Biological testing includes the following: Genotoxicity (ISO 10993-3), Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Irritation (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Sub-chronic Toxicity (ISO 10993-11), Chronic Toxicity (ISO 10993-11), Implantation (ISO 10993-6). All biocompatibility and chemical testing passed the requirements of EN ISO 10993, demonstrating biological safety. A Biological Risk Assessment (BRA) established the safety of the Expander, supported by information gathered from biological testing data on the material components, published literature and the long history of safe and effective use of the materials used to construct the device.
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.
DEN 150055
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
§ 878.3510 Carbon dioxide gas controlled tissue expander.
(a)
Identification. A carbon dioxide gas controlled tissue expander is a prescription device intended for temporary subcutaneous or submuscular implantation to stretch the skin for surgical applications, specifically to develop surgical flaps and additional tissue coverage. The device is made of an inflatable elastomer shell and is filled with carbon dioxide gas. The device utilizes a remote controller to administer doses of carbon dioxide gas from an implanted canister inside the device.(b)
Classification. Class II (special controls). The special controls for this device are:(1) In-vivo performance testing must be conducted to obtain the adverse event profile associated with use, and demonstrate that the device performs as intended under anticipated conditions of use.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance data must demonstrate the sterility of patient-contacting components of the device.
(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Cycle testing of expander showing that there are no leaks or tears after repeated cycling;
(ii) Mechanical assessment of implanted carbon dioxide (CO
2 ) canister including high impact testing;(iii) Leak testing of expander showing that device does not leak CO
2 ;(iv) Assessment of gas permeability during expansion and after full expansion; and
(v) Mechanical assessment of expander (tensile set, breaking force, shell joint test, and fused or adhered joint testing).
(5) Performance data must be provided to demonstrate the electromagnetic compatibility, electrical safety, and wireless compatibility of the device.
(6) Software verification, validation, and hazard analysis must be performed.
(7) Performance data must support shelf life by demonstrating continued sterility of the device or the sterile components, package integrity, and device functionality over the identified shelf life.
(8) Human factors testing and analysis must validate that the device design and labeling are sufficient for the end user.
(9) Physician labeling must include:
(i) The operating parameters, name, and model number of the indicated external dosage controller;
(ii) Information on how the device operates and the typical course of treatment;
(iii) Information on the population for which the device has been demonstrated to be effective;
(iv) A detailed summary of the device technical parameters; and
(v) Provisions for choosing an appropriate size implant that would be exchanged for the tissue expander.
(10) Patient labeling must include:
(i) Warnings, precautions, and contraindications, and adverse events/complications;
(ii) Information on how the device operates and the typical course of treatment;
(iii) The probable risks and benefits associated with the use of the device;
(iv) Post-operative care instructions; and
(v) Alternative treatments.
(11) Patient training must include instructions for device use, when it may be necessary to contact a physician, and cautionary measures to take when the device is implanted.
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Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three faces in profile, one behind the other. The seal is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 3, 2017
Airxpanders. Inc. Ms. Belinda Pinedo Director, Regulatory Affairs 1047 Elwell Ct. Palo Alto, California 94303
Re: K170075
Trade/Device Name: Aeroform Tissue Expander (v3.0), Aeroform Dosage Controller (v1.5) Regulation Number: 21 CFR 878.3510 Regulation Name: Carbon Dioxide Gas Controlled Tissue Expander Regulatory Class: Class II Product Code: PON Dated: January 6, 2017 Received: January 9, 2017
Dear Ms. Pinedo:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name AeroForm® Tissue Expander System
Indications for Use (Describe)
The AeroForm® Tissue Expander System is used for soft tissue expansion in breast reconstruction following mastectorny. for the treatment of underdeveloped breasts, and for the treatment of soft tissue deformities in the breast.
The AeroForm® Tissue Expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond 6 months.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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1. 510(K) SUMMARY
A 510(k) Summary begins on the next page and is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990. This 510(k) Summary meets the requirements identified in 21 CFR 807.92.
(The remainder of this page is intentionally left blank.)
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4.1 510(k) Summary
DATE OF SUMMARY
March 31, 2017
510(K) APPLICANT
AirXpanders, Inc. 1047 Elwell Court Palo Alto, California 94303 Phone: (650) 390-9000 FAX: (650) 390-9007
| Contact Person: | Belinda Pinedo |
|---|---|
| Phone: | (650) 390-8131 |
| Fax: | (650) 390-9007 |
| E-mail: | bpinedo@airxpanders.com |
Subject Device Overview
| Trade Name: | AeroForm® Tissue Expander System |
|---|---|
| Common Name: | Expander, Skin, Inflatable |
| Classification: | II |
| Product Code: | PQN |
| Regulation Name: | Carbon Dioxide Gas Controlled Tissue Expander |
PREDICATE DEVICE
The predicate device for this premarket submission is:
| Trade Name | Submitter | DeNovo Number |
|---|---|---|
| AeroForm® Tissue Expander System | AirXpanders, Inc. | DEN 150055 |
The predicate device has not been subjected to a design-related recall.
Device Description
The AeroForm Tissue Expander System (AeroForm System) is a sterile temporary implant for breast reconstruction and is comprised of a sterile, implantable tissue expander), a remote control (Controller), and a Master Key. The AeroForm Tissue Expander is a comprised of an outer textured silicone shell, an inner gas barrier (bag), with an internal reservoir of compressed Carbon Dioxide (CO2) gas, which is released within the Expander by using the remote control (Controller), resulting in gradual expansion of the Expander. In a typical, twostage breast reconstruction, a tissue expander device is placed under the pectoralis major muscle and remaining skin following a mastectomy procedure. The Expander is gradually
5
expanded over time through the release of carbon dioxide, causing the overlying skin and muscle to stretch. When adequate tissue coverage is achieved, the expansion device is removed and replaced with a breast implant.
Intended Use / Indications for Use
The AeroForm® Tissue Expander System is used in for soft tissue expansion in breast reconstruction following mastectomy, for treatment of underdeveloped breasts, and for the treatment of soft tissue deformities in the breast.
The AeroForm Tissue Expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.
TECHNOLOGICAL CHARACTERISTICS
The subject AeroForm Tissue Expander is a modification of the predicate AeroForm Tissue Expander. There are no technological differences between the subject device and the predicate device. Both the AeroForm System and the predicate AeroForm device cause expansion of the silicone shell of the expanders by incremental inflation with a gas medium, mechanically stretching the surrounding tissue. The breast tissue expanders are textured, and made of silicone.
The AeroForm System uses software and electronics to provide controlled, gradual expansion by pressing the button on the Controller, allowing carbon dioxide (CO2) to be released from a reservoir inside the Expander. A small amount of CO2 (10cc) is released and the Controller is programmed to allow the patient to dose up to 30cc per day. The Controller provides power to the Expander, which has a receiving antenna and electronics to enable communication with the Controller. The AeroForm System has been evaluated against safety and performance testing described in the tissue expander standard, as well as design verification and validation testing criteria in accordance with internal company controls and design control procedures to support the safety and intended use of the product.
PERFORMANCE DATA
Mechanical Performance Testing
Performance testing for the Expander included extensive evaluation of the device through performance and functional testing as described in ASTM F1441, Standard Specification for Soft Tissue Expanders. The following mechanical tests were performed:
- Endurance / Stress Tests (cycle, impact, elongation, and sustained pressure) ●
- . Break Force
- Fused or Adhered Joint Testing
- Overexpansion ●
6
All mechanical performance testing results met their pre-determined acceptance criteria and the requirements of ASTM standard for tissue expanders, demonstrating that the proposed device is substantially equivalent to the predicate device.
Sterilization and Package Integrity Testing
Sterilization validation, package integrity and shelf-life testing were performed, per applicable standards, demonstrating the package remains intact following climactic conditioning, gross leak, and seal strength testing.
Software Testing
Unit, System and Regression Testing was performed, as described in Software test plans and testing protocols. Software development is compliant with EN 62304, and applicable US FDA guidance documents.
Biocompatibility
The Expander was tested for biological safety according to the requirements of EN ISO 10993-1: "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing. Biological testing includes the following:
- Genotoxicity (ISO 10993-3) ●
- Cytotoxicity (ISO 10993-5)
- Sensitization (ISO 10993-10) ●
- Irritation (ISO 10993-10)
- Acute Systemic Toxicity (ISO 10993-11) .
- Sub-chronic Toxicity (ISO 10993-11)
- Chronic Toxicity (ISO 10993-11) ●
- Implantation (ISO 10993-6) ●
All biocompatibility and chemical testing passed the requirements of EN ISO 10993, demonstrating biological safety. A Biological Risk Assessment (BRA) established the safety of the Expander, supported by information gathered from biological testing data on the material components, published literature and the long history of safe and effective use of the materials used to construct the device.
Comparison to Predicate Device
The AeroForm Tissue Expander System has the same intended use and indications for use as the predicate device: intended for skin/tissue expansion. The System is intended for subcutaneous or submuscular implantation, and is not intended for use beyond six months and is a single-use device.
The subject and predicate device are based on the following comparable technological elements:
- . Same operating principle
- Same textured outer shell elastomeric material ●
- Same dimensional and volume ranges ●
- Suture tabs to attach device to surrounding tissue
- Compliance with recognized standards and test requirements. ●
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The principle of operation for both the AeroForm Expander and predicate device is the same: the silicone shell of the Expanders increases in size gradually with incremental filling of gas, resulting in stretching of the surrounding tissue. The main difference between the AeroForm Expander and the predicate device is the change in the barrier film material and the driver protection system.
There are no technological differences between the subject device and the predicate device. The subject AeroForm Expander has not introduced any new harms or risks and does not raise new types of safety and effectiveness questions compared to the predicate device. Performance testing shows effective mitigations that minimize patient overall risk to a level similar to the predicate device.
SPECIAL CONTROLS
AirXpanders complies with the general controls and good manufacturing practices and established quality system in compliance with 21 CFR 820. AirXpanders has determined that special controls are sufficient to provide assurance of the safety and effectiveness of the AeroForm Tissue Expander System. Special controls for the AeroForm Tissue Expander System include:
- . Design validation & In-vivo performance testing including clinical data, as presented in the predicate device DeNovo submission
- Biocompatibility
- Sterilization validation ●
- Design verification / non-clinical performance testing
- a) Cycle testing to ensure no leaks or tears in tissue expander
- b) High impact testing and mechanical assessment of implanted CO2 canister
- c) Leak testing showing that device does not leak CO2 with tissue expander
- d) Gas permeability assessment during and after full expansion
- e) Mechanical assessment of tissue expander (tensile set, breaking force, shell joint test, and fused or adhered joint testing)
- Electrical Safety & EMC testing ●
- Software validation ●
- Shelf life testing ●
- Human factors evaluation ●
- Labeling
- . Training
CONCLUSION
The subject AeroForm Tissue Expander System has identical intended use and indications for use and the same technological characteristics, principles of operation, and performance as the predicate device. Therefore, this device is considered substantially equivalent to the predicate AirXpanders AeroForm Tissue Expander device that was granted permission for marketing on December 21, 2016 per De Novo #DEN 150055. Performance and biological safety (biocompatibility) testing support the risk assessment and demonstrate that the
8
functionality, integrity, safety and effectiveness of the subject AeroForm Tissue Expander System are adequate for its intended use and support a determination of substantial equivalence to the predicate device.