(256 days)
No
The document describes a mechanical tissue expander and drain system with no mention of AI or ML technology.
No
The device is a tissue expander and a drain component used in surgical reconstruction and fluid management, not directly for diagnosis, cure, mitigation, treatment, or prevention of disease.
No
The device, AlloX2 Tissue Expander, is intended for temporary implantation to develop surgical flaps and additional tissue coverage, and also contains a silicone drain component. Its function is to expand tissue and drain fluids, not to diagnose medical conditions or diseases.
No
The device description clearly indicates it is a physical medical device constructed from silicone elastomer with an integral magnetic injection port and a drain component. It is intended for implantation.
Based on the provided information, the AlloX2 Tissue Expander is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- AlloX2 Function: The AlloX2 Tissue Expander is an implantable device used to physically expand tissue in the body. It is a surgical device, not a device that analyzes biological samples.
- Intended Use: The intended use clearly describes implantation for tissue expansion and drainage, not the analysis of biological specimens.
- Device Description: The description focuses on the physical construction and components of the implantable device.
- Performance Studies: The performance studies described are bench tests evaluating the physical properties and functionality of the device, not the accuracy of diagnostic measurements.
Therefore, the AlloX2 Tissue Expander falls under the category of a surgical implant or medical device used for physical manipulation of tissue, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
AlloX2 Tissue Expanders are intended for temporary (less than six months) subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstructions following mastectomy, to aid in the treatment of underdeveloped breasts and to aid in treatment of soft tissue deformities.
Additionally, the AlloX2 Tissue Expanders contain a silicone drain component which allows access to and drainage of latent fluids from the periprosthetic space. This drain component does not replace short-term, immediate, intraoperatively placed drains.
Product codes
LJC, LCI
Device Description
The AlloX2 Tissue Expanders are constructed as a unit from silicone elastomer and consist of a smooth or textured expansion envelope with an integral magnetic injection port. Specialty Surgical Products is proposing that an integral or remote (connected by tubing) drain port be integrated into the predicate device to facilitate the drainage of fluid in the periprosthetic pocket. The port design and magnetic technology/concept are the same as those of the predicate injection ports. The principles of operation of the subject device methodology are identical to that of the primary predicate Silicone Tissue Expander and the additional predicate Closed Wound Drain.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous or submuscular
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: Bench testing, Functional Testing
Sample Size: Not specified
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key results: The AlloX2 passed all testing and met all product specification requirements. The collective results of the performance testing demonstrates that the AlloX2 meets all established product specification requirements and does not raise any new questions of safety or effectiveness as compared to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure. The symbol is composed of three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2014
Specialty Surgical Products Incorporated Ms. Sherry Null Vice President, Regulatory Affairs 1123 North U.S. Highway 93 Victor, Montana 59875
Re: K140383
Trade/Device Name: AlloX2 Tissue Expanders Regulatory Class: Unclassified Product Code: LJC Dated: September 30, 2014 Received: October 1, 2014
Dear Ms. Null:
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
1
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. 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" (21CFR 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 yours,
David Krause -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) K140383
Device Name AlloX2 Tissue Expanders
Indications for Use (Describe)
AlloX2 Tissue Expanders are intended for temporary (less than six months) subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstructions following mastectomy, to aid in the treatment of underdeveloped breasts and to aid in treatment of soft tissue deformities.
Additionally, the AlloX2 Tissue Expanders contain a silicone drain component which allows access to and drainage of latent fluids from the periprosthetic space. This drain component does nort-term, immediate, intraoperatively placed drains.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
510(k) Notification K140383
GENERAL INFORMATION
Applicant:
Specialty Surgical Products, Inc. 1123 North U.S. Highway 93 Victor, MT 59875 U.S.A. Phone: 406-961-0102 Fax: 406-961-0103
Contact Person:
Sherry Null Vice President, Regulatory Affairs Specialty Surgical Products, Inc. 1123 North U.S. Highway 93 Victor, MT 59875 U.S.A. Phone: 406-961-0102 Fax: 406-961-0103 Email: snull@ssp-inc.com
Date Prepared: October 23, 2014
Classification: Unclassified (pre-amendment)
Product Code: LCI
Trade Name: AlloX2 Tissue Expanders
Generic/Common Name: Expander, skin, inflatable
Primary Predicate Device Silicone Tissue Expanders (K070303)
Additional Predicate Device Heyer Schulte (Jackson-Pratt) Closed Wound Drain (K801766)
Indications for Use
AlloX2 Tissue Expanders are intended for temporary (less than six month) subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstructions following mastectomy, to aid in the treatment of underdeveloped breasts and to aid treatment of soft tissue deformities.
Additionally, the AlloX2 Tissue Expanders contain a silicone drain component which allows access to and drainage of fluids from the periprosthetic space. This drain component does not replace short-term, immediate, intraoperatively placed drains.
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510(k) SUMMARY (CONT.)
The AlloXo Tissue Expander configurations are substantially equivalent in material, function, performance and design to the Silicone Tissue Expanders marketed by Specialty Surgical Products cleared via 510(k) submission K070303. The AlloX2 configurations are substantially equivalent in material, function and performance to the Heyer Schulte (Jackson-Pratt) Closed Wound Drains cleared via 510(k) submission K801766.
Relevant testing was performed in accordance with ASTM F1441-03 "Standard Specification for Soft-Tissue Expander Devices." The following table lists bench testing performed and the results for each test.
| Testing Type | Test Description | Results |
|---|---|---|
| Testing in accordance with | ||
| ASTM F1441-03 | Tube Shell Junction | The AlloX2 passed all |
| testing and met all product | ||
| specification requirements. | ||
| Injection/Drain Port | ||
| Competence | ||
| Overexpansion | ||
| Tubing Length Adapter | ||
| Strength | ||
| Critical Fused Joint | ||
| Functional Testing | Adhered Joint | The AlloX2 passed all |
| functional testing and met | ||
| all product specification | ||
| requirements. | ||
| Drain System | ||
| Magnetic Detection |
The collective results of the performance testing demonstrates that the AlloX2 meets all established product specification requirements and does not raise any new questions of safety or effectiveness as compared to the predicate device.
Product Description
The AlloX2 Tissue Expanders are constructed as a unit from silicone elastomer and consist of a smooth or textured expansion envelope with an integral magnetic injection port. Specialty Surgical Products is proposing that an integral or remote (connected by tubing) drain port be integrated into the predicate device to facilitate the drainage of fluid in the periprosthetic pocket. The port design and magnetic technology/concept are the same as those of the predicate injection ports. The principles of operation of the subject device methodology are identical to that of the primary predicate Silicone Tissue Expander and the additional predicate Closed Wound Drain.
The proposed AlloX2 Tissue Expanders will have the same indications for use as the primary predicate device, the Silicone Tissue Expander (K070303) and the same intended use as the additional predicate Closed Wound Drain (K801766).
Substantial Equivalence
The AlloX2 Tissue Expanders are substantially equivalent to the predicate devices with regard to function, intended use and technological characteristics. Any differences in the technological characteristics between the devices do not raise any new issues of safety or
5
510(k) SUMMARY (CONT.)
efficacy. Thus, the proposed AlloX2 Tissue Expanders are substantially equivalent to the predicate devices.
Conclusion
The proposed AlloX2 Tissue Expanders have the same technological characteristics as the predicate devices. The differences in design do not change the indications for use/intended use for the primary predicate SSP Silicone Tissue Expander #K070303 and do no change the intended use of the additional predicate Heyer Schulte (Jackson-Pratt) Closed Wound Drain (K801766) or raise any new issues of safety or effectiveness as compared to the predicates.
Summary
The AlloX2 Tissue Expanders are substantially equivalent to the predicate devices.