(72 days)
No
The description details a mechanical tissue expander system controlled by a remote, with no mention of AI or ML capabilities for decision-making, analysis, or control.
Yes.
The device is used to expand soft tissue for breast reconstruction and treatment of underdeveloped breasts and soft tissue deformities, which are therapeutic applications.
No
The device is described as a sterile, temporary implant for breast reconstruction used for soft tissue expansion, not for diagnosing medical conditions.
No
The device description clearly states it is comprised of an implantable tissue expander, a remote control, and a Master Key, all of which are hardware components.
Based on the provided information, the AeroForm® Tissue Expander System, Smooth 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 procedure involving an implantable device, not a diagnostic test performed on samples taken from the body (in vitro).
- Device Description: The device is described as a sterile, temporary implant for breast reconstruction. It is a physical device implanted into the body to facilitate tissue expansion.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) outside of the body to provide diagnostic information.
Therefore, the AeroForm® Tissue Expander System, Smooth falls under the category of a medical device used for surgical and reconstructive purposes, not an IVD.
N/A
Intended Use / Indications for Use
The AeroForm® Tissue Expander System, Smooth 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.
The AeroForm® Tissue Expander, Smooth is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months
Product codes
PON
Device Description
The AeroForm Tissue Expander System, Smooth is a sterile, temporary implant for breast reconstruction. This device is comprised of an implantable tissue expander (Expander), a remote control (Controller), and a Master Key. The AeroForm Tissue Expander, Smooth is constructed of an outer silicone shell and an inner gas barrier (bag) with an internal reservoir of compressed Carbon Dioxide (CO2) gas. The CO2 gas is released within the Expander by using the remote control (Controller), resulting in gradual expansion of the Expander. In a typical, two-stage 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
Mechanical Performance Testing
Testing was performed, as required, to verify and validate that the design outputs of the modified device meet the design input requirements. Performance testing for the smooth Expander included 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:
- Simulated Use Testing .
- Endurance / Stress Tests .
- Dimensional Measurement .
- Shell Tensile Set, Shell Break Force, Non-Critical Fused or Adhered Joints ●
All mechanical performance testing results met their pre-determined acceptance criteria and the requirements of the ASTM F1441 standard for tissue expanders, demonstrating that the modified device is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 11, 2019
AirXpanders, Inc. Belinda Pinedo Director, Regulatory Affairs 3047 Orchard Parkway San Jose, California 95134
Re: K191138
Trade/Device Name: AeroForm Tissue Expander, Smooth Regulation Number: 21 CFR 878.3510 Regulation Name: Carbon Dioxide Gas-Controlled Tissue Expander Regulatory Class: Class II Product Code: PON Dated: June 10, 2019 Received: June 11, 2019
Dear Belinda 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Nina Mezu-Nwaba, PharmD., MPH., MSc. CAPT., United States Public Health Service Assistant Director (Acting), Plastic Surgery Implant Devices Team Division of Infection Control and Plastic Surgery Devices Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020 See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name AeroForm Tissue® Expander System, Smooth
Indications for Use (Describe)
The AeroForm® Tissue Expander System, Smooth 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.
The AeroForm® Tissue Expander, Smooth is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months
| Type of Use (Select one or both, as applicable) |
|---|
| ✔ Prescription Use (Part 21 CFR 801 Subpart D) ▢ Over-The-Counter Use (21 CFR 801 Subpart C) |
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| FORM FDA 3881 (7/17) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | EF |
|---|---|---|---|
| ---------------------- | ------------- | ---------------------------------------- | ---- |
Indications For Use Statement
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3.1 510(k) Summary
DATE OF SUMMARY
April 29, 2019
510(K) Applicant
AirXpanders, Inc. 3047 Orchard Parkway San Jose, California 95134 Phone: (650) 282-8131
Contact Person: Belinda Pinedo Phone: (650) 282-8131 E-mail: bpinedo@airxpanders.com
Subject Device Overview
| Trade Name: | AeroForm® Tissue Expander System, Smooth |
|---|---|
| Common Name: | Expander, Skin, Inflatable |
| Classification: | II |
| Product Code: | PQN |
| Regulation Number: | 21 CFR 878.3510 |
| Regulation Name: | Carbon Dioxide Gas Controlled Tissue Expander |
Predicate Device
The predicate device for this premarket submission is:
| Trade Name | Submitter | 510(k) Number | 510(k)
Clearance Date |
|----------------------------------|-------------------|---------------|--------------------------|
| AeroForm® Tissue Expander System | AirXpanders, Inc. | K170075 | 04/03/2017 |
Reference Devices
There are other tissue expanders with a smooth shell construction that have been cleared as a Special 510(k); these are referenced below.
| Trade Name | Manufacturer
Name | 510(k)
Number | 510(k)
Clearance Date |
|----------------------------------------------------|----------------------|------------------|--------------------------|
| Natrelle 133S Tissue Expander | Allergan | K182054 | 08/29/2018 |
| Artoura Breast Tissue Expander with Smooth Surface | Mentor | K161176 | 05/23/2016 |
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DEVICE DESCRIPTION
The AeroForm Tissue Expander System, Smooth is a sterile, temporary implant for breast reconstruction. This device is comprised of an implantable tissue expander (Expander), a remote control (Controller), and a Master Key. The AeroForm Tissue Expander, Smooth is constructed of an outer silicone shell and an inner gas barrier (bag) with an internal reservoir of compressed Carbon Dioxide (CO2) gas. The CO2 gas is released within the Expander by using the remote control (Controller), resulting in gradual expansion of the Expander. In a typical, two-stage 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.
Intended Use / Indications for Use
The AeroForm® Tissue Expander System, Smooth is used 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, Smooth is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.
TECHNOLOGICAL CHARACTERISTICS
The subject AeroForm Tissue Expander, Smooth has a modified outer shell that has a smooth surface finish, as opposed to the predicate AeroForm Tissue Expander which has a textured outer shell. This change does not alter the fundamental scientific technology of the device. The subject Expander is made of the same material as the predicate device, but eliminates the final outer shell texture processing, which results in a smooth outer shell surface.
Both the AeroForm Tissue Expander, Smooth and the predicate AeroForm device expand with the same internal operating mechanism which includes an internal Driver reservoir that contains a gas medium that when actuated, releases incremental inflations that gradually stretch the surrounding tissue.
The AeroForm Tissue Expander System, Smooth 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 Tissue Expander System, Smooth has been evaluated against safety and performance testibed in the tissue expander standard, as well as design verification and validation testing criteria in accordance with
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internal company controls and design control procedures to support the safety and intended use of the product.
PERFORMANCE DATA
Mechanical Performance Testing
Testing was performed, as required, to verify and validate that the design outputs of the modified device meet the design input requirements. Performance testing for the smooth Expander included 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:
- Simulated Use Testing .
- Endurance / Stress Tests .
- Dimensional Measurement .
- Shell Tensile Set, Shell Break Force, Non-Critical Fused or Adhered Joints ●
All mechanical performance testing results met their pre-determined acceptance criteria and the requirements of the ASTM F1441 standard for tissue expanders, demonstrating that the modified device is substantially equivalent to the predicate device.
COMPARISON TO PREDICATE DEVICE
The AeroForm Tissue Expander System, Smooth has the same intended use and indications for use as the predicate device: intended for skin/tissue expansion. The System is a single-use device and is intended for subcutaneous or submuscular implantation and is not intended for use beyond six months.
The subject and predicate devices are based on the following comparable technological elements:
- . Same operating principle
- Same outer shell elastomeric material ●
- Same dimensional and volume ranges ●
- . Suture tabs to attach device to surrounding tissue
- . Compliance with recognized standards and test requirements.
The principle of operation for both the AeroForm Tissue Expander, Smooth and predicate device is the same: the silicone shell of the Expanders gradually increases
6
in size with incremental filling of gas, resulting in stretching of the surrounding tissue. The main difference between the AeroForm Tissue Expander, Smooth and the predicate device is the change in the surface texture of the outer shell. The predicate device is made of a textured outer shell, and the subject device is made of a smooth outer shell where no texture is applied.
There are no technological differences between the subject device and the predicate device. The subject AeroForm Tissue Expander has not introduced any new harms or risks and does not raise new types of safety or effectiveness questions compared to the predicate device.
CONCLUSION
The subject AeroForm Tissue Expander System has an identical intended use and indications for use, principles of operation, performance, and technological characteristics with the exception of the shell surface texture, as the predicate device. No new risks were introduced as a result of the device modifications discussed in this submisssion. Performance testing supports the risk assessment and demonstrate that the functionality, integrity, safety and effectiveness of the subject AeroForm Tissue Expander System, Smooth as compared to the predicate device are adequate for its intended use.
Therefore, this device is considered substantially equivalent to the AirXpander's predicate AeroForm Tissue Expander device that was FDA cleared on April 3, 2017 in 510(k) #K170075.