(154 days)
The Compressyn™ Band is intended for use in stabilization of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.
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.
This Dallen Medical, Inc. 510(k) submission (K130431) describes the Compressyn™ Band, a cerclage bone fixation device. The submission focuses on demonstrating substantial equivalence to a predicate device (Compressyn™ Band, K101484) rather than establishing new performance criteria.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Outcome) |
|---|---|
| Sternal Compression (Implied function of the device) | "The testing demonstrated that the Compressyn™ Band is substantially equivalent to the predicate device." |
| Static Performance (Implied mechanical strength) | "The testing demonstrated that the Compressyn™ Band is substantially equivalent to the predicate device." |
| Cyclic Performance to 2000 cycles (Implied durability) | "The testing demonstrated that the Compressyn™ Band is substantially equivalent to the predicate device." |
Note: The document explicitly states that the device has "similar physical and technical characteristics to the predicate device" and that "all necessary verification and validation testing has been performed... to assure substantial equivalence to the predicate device." The acceptance criteria were not quantitative, but rather qualitative: demonstrating substantial equivalence to the previously cleared predicate device for the specified performance tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the sample size used for the sternal compression, static, or cyclic performance tests. It simply states "Comparative testing."
- Data Provenance: Not specified, but implied to be laboratory testing conducted by or for Dallen Medical, Inc. (retrospective in relation to the submission date). No human patient data is mentioned; the "performance data" refers to mechanical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device's performance was evaluated through mechanical, engineering-based tests, not through expert-reviewed clinical or imaging data. The "ground truth" was established by the physical and mechanical properties of the predicate device, against which the new device was compared.
4. Adjudication Method for the Test Set
Not applicable, as this was a mechanical engineering study, not a clinical study requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a medical device (cerclage band) and the performance data described is mechanical testing. MRMC studies are typically used for diagnostic devices (e.g., AI algorithms for image interpretation).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation was the established mechanical performance and characteristics of the predicate device (Compressyn™ Band, K101484). The goal of the study was to demonstrate that the new device performed equivalently to the predicate.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a training set as this is a mechanical device, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable. See point 8.
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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.
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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.
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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
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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
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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
§ 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.