(308 days)
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.
The Compressyn™ Band System consists of a stainless steel coupler preloaded with a 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.
The acceptance criteria and study proving the device meets them are summarized below based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Sternal compression | Not explicitly stated; device found substantially equivalent to predicates. |
| Static performance to a 5mm gap | Not explicitly stated; device found substantially equivalent to predicates. |
| Static performance to point of failure | Not explicitly stated; device found substantially equivalent to predicates. |
| Cyclic performance to a 5mm gap | Not explicitly stated; device found substantially equivalent to predicates. |
| Cyclic performance to point of failure | Not explicitly stated; device found substantially equivalent to predicates. |
| Cyclic performance to 2000 cycles | Not explicitly stated; device found substantially equivalent to predicates. |
Note: The document states, "The testing demonstrated that the Compressyn™ Band is substantially equivalent to the predicate devices." Specific numerical acceptance criteria and the Compressyn™ Band's performance against them are not provided, only that the outcome met the substantial equivalence criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size for the test set (number of devices tested) or the data provenance (country of origin, retrospective/prospective). It only mentions that "All necessary verification and validation testing has been performed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is a medical device (cerclage bone fixation) testing, not an AI or diagnostic imaging study that would require expert-established ground truth. The testing involves mechanical and performance characteristics.
4. Adjudication Method for the Test Set
N/A. The testing described is performance-based (mechanical tests) typically without human adjudication in the context of diagnostic agreement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
N/A. This is a medical device (cerclage bone fixation) testing, not an AI or diagnostic imaging study that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This device is a physical medical implant, not an algorithm.
7. The Type of Ground Truth Used
For the performance testing, the "ground truth" or reference for comparison appears to be the performance characteristics of the predicate devices. The study aimed to demonstrate "substantial equivalence" of the Compressyn™ Band's mechanical and physical performance to these predicate devices. The specific physical properties or failure points of the predicate devices would form the benchmark for comparison.
8. The Sample Size for the Training Set
N/A. This is not an AI/machine learning study, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
N/A. As there is no training set for an AI model, this question is not applicable.
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KIOI 484
- 510 (k) Summary
APR - 1 2011
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 GSan Clemente, CA 92673(949) 218-0030(949) 218-0040 Fax |
|---|---|
| CONTACT PERSON: | Al MemmoloChief Operations Officer |
| DATE PREPARED: | March 28, 2011 |
| DEVICE DESCRIPTION: | |
| TRADE NAME: | CompressynTM Band |
| GENERIC/COMMON NAME | Cerclage Bone Fixation |
| CLASSIFICATION NAME | Bone Fixation, Cerclage, CFR 888.3010 (code JDQ) |
| DEVICE CLASSIFICATION | Class II |
| PREDICATE DEVICES: | KLS Martin Sternal Talon (K070169)Sternal Band (K930015)Pioneer Sternal Cable System (K993286)Mersilene Polyester Fiber Suture (pre-amendment device)Ethicon Stainless Steel Suture Wire (K931271/ K946173)Synthofil Nonabsorbable PET Surgical Suture (K990088) |
Product Description:
The Compressyn™ Band System consists of a stainless steel coupler preloaded with a 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.
Page 1 of 2
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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.
Technical Characteristics:
The Compressyn™ Band has similar physical and technical characteristics to the predicate devices.
Performance Data:
All necessary verification and validation testing has been performed with the Compressyn ™ Band to assure substantial equivalence to the predicate devices. Comparative testing against predicate devices included the following tests:
- Sternal compression .
- Static performance to a 5mm gap .
- Static performance to point of failure .
- Cyclic performance to a 5mm gap .
- Cyclic performance to point of failure .
- Cyclic performance to 2000 cycles ●
The testing demonstrated that the Compressyn™ Band is substantially equivalent to the predicate devices.
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 by Dallen Medical, to be substantially equivalent to existing legally marketed devices.
Page 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines and a wavy line at the bottom.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dallen Medical, Inc. % Mr. Al Memmolo Chief Operations Officer 1046 Calle Recodo, Suite G San Clemente, California 92673
Re: K101484
Trade/Device Name: Compressyn™ Band Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: March 23, 2011 Received: March 24, 2011
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
APR - 1 200
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Page 2 – Mr. Al Memmolo
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Kry 13. 12. fr
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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- Indications for Use Statement
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): KIO|481
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.
X Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
M. Melleerson
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101481
Page 1 of 1
Dallen Medical Compressyn Band
§ 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.