(226 days)
Reprocessed Cardiac Stabilization and Positioning Devices are indicated for use during performance of minimally invasive cardiovascular surgery through a sternotomy incision approach on the non-arrested heart. Sternum retractor blades are used to provide access to the thoracic cavity and to provide a mount for the tissue stabilizer and heart positioner. It also facilitates the positioning of pericardial sutures. The tissue stabilizer is used to stabilize and minimize the motion of selected sites on the beating heart. The heart positioner aids in positioning the heart by the application of vacuum suction when positioned on the heart.
Cardiac stabilization and positioning devices are specially designed devices used in minimally invasive cardiac surgery for coronary artery bypass grafting. The devices offer a retraction as well as a stabilizing function to control the movement of the beating heart. The cardiac stabilization and positioning devices consist of a combination of one or more of the following components: tissue stabilizer, heart positioner, and sternum retractor blades.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Reprocessed Cardiac Stabilization and Positioning Devices, presented in the requested format:
Acceptance Criteria and Study Information (K070036)
This submission describes the reprocessing of existing cardiac stabilization and positioning devices. As such, the "device" being evaluated is the reprocessed version of already marketed devices. The performance evaluation focuses on demonstrating that the reprocessed devices are equivalent in safety and effectiveness to the original, brand-new devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material & Design Equivalence | The design, materials, and intended use of Reprocessed Cardiac Stabilization and Positioning Devices are identical to the predicate devices. | Demonstrated: "The design, materials, and intended use of Reprocessed Cardiac Stabilization and Positioning Devices are identical to the predicate devices." "The mechanism of action of Reprocessed Cardiac Stabilization and Positioning Devices is identical to the predicate devices in that the same standard mechanical design, materials, and size are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." |
| Functional Equivalence | The mechanism of action, performance specifications, and method of operation of Reprocessed Cardiac Stabilization and Positioning Devices are identical to the predicate devices. Each individual reprocessed device is tested for appropriate function of its components. | Demonstrated: "The mechanism of action of Reprocessed Cardiac Stabilization and Positioning Devices is identical to the predicate devices in that the same standard mechanical design, materials, and size are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation." "Each individual Cardiac Stabilization and Positioning Device is tested for appropriate function of its components prior to packaging and labeling operations." "Performance testing demonstrates that Reprocessed Cardiac Stabilization and Positioning Devices perform as originally intended." |
| Biocompatibility | The reprocessed devices must be biocompatible, ensuring no unacceptable biological response due to reprocessing. | Demonstrated: "Biocompatibility Validation of reprocessing" was conducted. (No specific numerical criteria or results are provided in this summary, but the completion of validation implies meeting internal standards.) |
| Reprocessing Sterility | The reprocessing must render the devices sterile to an acceptable level (e.g., Sterility Assurance Level - SAL). | Demonstrated: "Sterilization Validation" was conducted. (No specific numerical criteria or results are provided in this summary, but the completion of validation implies meeting internal standards.) |
| Packaging Integrity | The packaging for the reprocessed devices must maintain sterility and product integrity. | Demonstrated: "Packaging Validation" was conducted. (No specific numerical criteria or results are provided in this summary, but the completion of validation implies meeting internal standards.) |
| Cleanliness / Decontamination | Reprocessing steps must include removal of adherent visible soil and decontamination. | Demonstrated: "Ascent Healthcare Solutions's reprocessing of Cardiac Stabilization and Positioning Devices includes removal of adherent visible soil and decontamination." |
| Overall Safety & Effectiveness | The reprocessed devices are safe, effective, and substantially equivalent to the predicate devices. | Demonstrated: "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Cardiac Stabilization and Positioning Devices." "Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Cardiac Stabilization and Positioning Devices) are safe, effective, and substantially equivalent to the predicate devices as described herein." This conclusion implies that all individual criteria were met. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test (Biocompatibility, Sterilization Validation, Function Test(s), Packaging Validation). The data provenance is described as "Bench and laboratory testing," implying internal testing conducted by Ascent Healthcare Solutions. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of clinical data, as this submission pertains to reprocessing, not a new clinical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This submission is for reprocessed medical devices, and the "ground truth" is primarily based on meeting engineering and performance specifications of the original device, rather than expert interpretation of medical images or conditions. The testing would be conducted by qualified laboratory personnel and engineers, but the document does not specify their number or qualifications.
4. Adjudication method for the test set
Not applicable. The "tests" described are bench and laboratory tests (biocompatibility, sterility, function, packaging). These tests typically involve objective measurements against predefined specifications, rather than a subjective adjudication process by multiple experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This submission is for reprocessed cardiac surgical instruments, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for reprocessed cardiac surgical instruments, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the reprocessed device's performance is essentially the established performance and safety profile of the original, predicate device. The studies (bench and lab tests) aim to demonstrate that the reprocessed device performs identically to this established baseline. Specific types of ground truth used include:
- Engineering Specifications: For function tests, comparing reprocessed device performance against original design specifications.
- Validated Protocols: For biocompatibility and sterilization, adherence to recognized standards and validated protocols.
- Material Properties: Ensuring reprocessed materials maintain their original properties.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
{0}------------------------------------------------
SECTION 5: 510(k) SUMMARY
AUG | 7 2007
| Submitter: | Ascent Healthcare Solutions10232 South 51st StreetPhoenix, Arizona 85044 |
|---|---|
| Contact: | Katie BrayRA Specialist/Biomedical Engineer(480) 763-5300 (o)(480) 763-6089 (f)kbray@ascenths.com |
| Date of preparation: | December 29, 2006 |
| Name of device: | Trade/Proprietary Name: Reprocessed Cardiac Stabilization andPositioning Devices |
| Classification Name: Cardiovascular surgical instruments | |
| Predicate Device | |
| K041338 | 510(k) TitleMedtronic Octopus TE Stabilizer &Accessories |
| ManufacturerMedtronic | |
| K964445 | Medtronic Octopus Tissue Stabilizer |
| Medtronic | |
| Note: These are class I devices that do not require a 510(k) for original (brand new) devices. Therefore, the predicate device may not have a filed 510(k) from the original manufacturer. | |
| Device description: | Cardiac stabilization and positioning devices are speciallydesigned devices used in minimally invasive cardiac surgery forcoronary artery bypass grafting. The devices offer a retractionas well as a stabilizing function to control the movement of thebeating heart. The cardiac stabilization and positioning devicesconsist of a combination of one or more of the followingcomponents: tissue stabilizer, heart positioner, and sternumretractor blades. |
| Indications for Use: | Reprocessed Cardiac Stabilization and Positioning Devices areindicated for use during performance of minimally invasivecardiovascular surgery through a sternotomy incision approachon the non-arrested heart. Sternum retractor blades are used toprovide access to the thoracic cavity and to provide a mount forthe tissue stabilizer and heart positioner. It also facilitates thepositioning of pericardial sutures. The tissue stabilizer is used tostabilize and minimize the motion of selected sites on thebeating heart. The heart positioner aids in positioning the heartby the application of vacuum suction when positioned on theheart. |
CONFIDENTIAL
, … "
:
{1}------------------------------------------------
| Technologicalcharacteristics: | The design, materials, and intended use of ReprocessedCardiac Stabilization and Positioning Devices are identical to thepredicate devices. The mechanism of action of ReprocessedCardiac Stabilization and Positioning Devices is identical to thepredicate devices in that the same standard mechanical design,materials, and size are utilized. There are no changes to theclaims, intended use, clinical applications, patient population,performance specifications, or method of operation. In addition,Ascent Healthcare Solutions's reprocessing of CardiacStabilization and Positioning Devices includes removal ofadherent visible soil and decontamination. Each individualCardiac Stabilization and Positioning Device is tested forappropriate function of its components prior to packaging andlabeling operations. |
|---|---|
| Performance data: | Bench and laboratory testing was conducted to demonstrateperformance (safety and effectiveness) of Reprocessed CardiacStabilization and Positioning Devices. This included thefollowing tests: |
| Biocompatibility Validation of reprocessing Sterilization Validation Function test(s) Packaging Validation | |
| Performance testing demonstrates that Reprocessed CardiacStabilization and Positioning Devices perform as originallyintended. | |
| Conclusion: | Ascent Healthcare Solutions concludes that the modifieddevices (Reprocessed Cardiac Stabilization and PositioningDevices) are safe, effective, and substantially equivalent to thepredicate devices as described herein. |
CONFIDENTIAL
:
:
:
{2}------------------------------------------------
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" arranged around the perimeter. Inside the circle is a stylized representation of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 7 2007
Ascent Healthcare Solutions c/o Ms. Katie Bray Regulatory Affairs Engineer 10232 South 51st Street Phoenix, AZ 85044
Re: K070036
Reprocessed Medtronic Cardiac Stabilization and Positioning Devices Regulation Number: 21 CFR 870.4500 Regulation Name: Cardiovascular Surgical Instruments Regulatory Class: Class I non-exempt Product Code: NQG Dated: July 20, 2007 Received: July 23, 2007
Dear Ms. Bray:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
{3}------------------------------------------------
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
B.Jemimon for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
| ProCode | Family | Model |
|---|---|---|
| NQG | Medtronic HeartStabilizers andPositioners | Octopus 3.0 Stabilizer |
| Octopus 4.0 Stabilizer | ||
| Octopus 4.3 Stabilizer | ||
| Starfish Heart Positioner | ||
| Starfish 2 Positioner | ||
| Evolution | ||
| Urchin Positioner |
{5}------------------------------------------------
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known): 《(070036
Device Name: Reprocessed Medtronic Cardiac Stabilization and Positioning Devices
Indications For Use:
Reprocessed Cardiac Stabilization and Positioning Devices are indicated for use during performance of minimally invasive cardiovascular surgery through a sternotomy incision approach on the non-arrested heart. Sternum retractor blades are used to provide access to the thoracic cavity and to provide a mount for the tissue stabilizer and heart positioner. It also facilitates the positioning of pericardial sutures. The tissue stabilizer is used to stabilize and minimize the motion of selected sites on the beating heart. The heart positioner aids in positioning the heart by the application of vacuum suction when positioned on the heart.
B.H.mmanama
Division Sign-Division of Cardiove 510(k) Number
AND/OR
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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)
CONFIDENTIAL
Ascent Healthcare Solutions Reprocessed Cardiac Stabilization and Positioning Devices Traditional 510(k)
Page 10
§ 870.4500 Cardiovascular surgical instruments.
(a)
Identification. Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.