(154 days)
Not Found
No
The device description and performance studies focus on mechanical properties and fixation, with no mention of AI/ML terms or functionalities.
Yes
The device is intended for the "stabilization of anterior chest wall fractures," which is a therapeutic purpose.
No
Explanation: The device is described as a cerclage fixation device used for stabilization of fractures and procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it consists of a stainless steel coupler and a polymer coated polyester fiber band, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "stabilization of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures." This describes a surgical or medical device used in vivo (within the body) for structural support and fixation.
- Device Description: The description details a "cerclage fixation device that is placed around or through the sternum and locked in place to provide stabilized fixation." This further confirms its use as an implantable or externally applied device for physical support.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or point-of-care settings for testing biological samples.
Therefore, the Compressyn™ Band is a medical device used for surgical fixation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Compressyn™ Band is intended for use in stabilization of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.
Product codes (comma separated list FDA assigned to the subject device)
JDQ
Device Description
The Compressyn™ Band System consists of a stainless steel coupler preloaded with a polymer coated polyester fiber band. It is a cerclage fixation device that is placed around or through the sternum and locked in place to provide stabilized fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior chest wall, sternum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
All necessary verification and validation testing has been performed with the Compressyn™ Band to assure substantial equivalence to the predicate device. Comparative testing in comparison to the predicate device included the following tests:
- Sternal compression
- Static performance .
- Cyclic performance to 2000 cycles .
The testing demonstrated that the Compressyn™ Band is substantially equivalent to the predicate 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.
Compressyn™ Band (K101484)
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
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
Dallen Medical, Inc. 510(k) K130431 - Amendment 2 June 6, 2013 – Compressyn™ Band_Model 09-0002, 09-0005
Image /page/0/Picture/1 description: The image shows the logo for Dallen Medical. The words "dallen" and "medical" are stacked on top of each other. Above the word "dallen" is the text "(page 1/2)".
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
GENERAL INFORMATION
| APPLICANT: | Dallen Medical, Inc. |
|---|---|
| 1046 Calle Recodo, Suite G | |
| San Clemente, CA 92673 | |
| (949) 218-0030 | |
| (949) 218-0040 Fax | |
| JUL 2 5 2013 | |
| CONTACT PERSON: | Al Memmolo |
| Chief Operating Officer | |
| DATE PREPARED: | June 6, 2013 |
| DEVICE DESCRIPTION: | |
| TRADE NAME: | Compressyn™ Band |
| MODEL: | 09-0002, 09-0005 |
| GENERIC/COMMONNAME | Cerclage Bone Fixation |
| CLASSIFICATION NAME: | Bone Fixation, Cerclage, CFR 888.3010 (code JDQ) |
| DEVICE CLASSIFICATION: | Class II |
| PREDICATE DEVICES: | Compressyn™ Band (K101484) |
Product Description:
The Compressyn™ Band System consists of a stainless steel coupler preloaded with a polymer coated polyester fiber band. It is a cerclage fixation device that is placed around or through the sternum and locked in place to provide stabilized fixation.
1
Image /page/1/Picture/1 description: The image shows the text "(page 2/2)" at the top, followed by the word "dallen" in a large, bold font. Below "dallen" is the word "MEDICAL" in a smaller, outlined font. The image appears to be a logo or header for a medical company called Dallen Medical.
Indications for Use:
The Compressyn™ Band is intended for use in stabilization of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.
Technical Characteristics:
The Compressyn™ Band has similar physical and technical characteristics to the predicate device.
Performance Data:
All necessary verification and validation testing has been performed with the Compressyn™ Band to assure substantial equivalence to the predicate device. Comparative testing in comparison to the predicate device included the following tests:
- Sternal compression
- Static performance .
- Cyclic performance to 2000 cycles .
The testing demonstrated that the Compressyn™ Band is substantially equivalent to the predicate device.
Basis for Determination of Substantial Equivalence:
Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation, performance data, and overall technological characteristics, the Compressyn™ Band is determined to be substantially equivalent to existing legally marketed devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three wavy lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2013
Dallen Medical. Incorporated % Mr. Al Memmolo Chief Operating Officer 1046 Calle Recodo, Suite G San Clemente, California 92673
Re: K130431
Trade/Device Name: Compressyn™ Band Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Date: June 6, 2013 Received: June 7, 2013
Dear Mr. Memmolo:
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
3
Page 2 - Mr. Al Memmolo
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers. International and Consumer Assistance 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.
.fda.gov/medicaldevices/resourcesforyou/ucm41.a
Sincerely yours,
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Page 1 of 1
K130431 510(k) Number (if known):
Device Name: Compressyn™ Band
Indications for Use:
The Compressyn™ Band is intended for use in stabilization and fixation of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.
Prescription Use _ X (Per 21 CFR 801.109) OR
Over-The-Counter-Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley Ph.D.
Division of Orthopedic Devices