(60 days)
The Medtronic Octopus TE Stabilizer is used to stabilize the epicardial surface of the non-arrested heart during coronary artery surgery. It is intended to be used by trained medical professionals in operating room environments.
The Stabilizer is intended to stabilize the epicardial surface of the nonarrested heart during coronary artery surgery. It is intended to be used only by medical professionals in operating room environments.
The non-sterile, reusable Medtronic Octopus TE Heart Stabilizing System is a suction-based tissue stabilizer with a collapsible pod assembly, a rigid shaft and 5 articulating links designed to enable transfer into the thoracic cavity via a 12 mm thoracic port or traditional sternotomy access. It is comprised of four distinct elements: (1) the Medtronic Octopus TE Tissue Stabilizer, (2) the Medtronic Octopus TE Suction Lines, (3) the Medtronic Octopus TE Vacuum Lines, and (4) the Medtronic Octopus TE Irrigator (optional).
The Medtronic Octopus TE Heart Stabilizer is secured to a flexible arm and universal mounting rail, which attached to the operating table rail. Vacuum is delivered to the pod assembly by a disposable suction line inserted through the shaft of the stabilizer and a disposable vacuum line that connects the stabilizer to the vacuum source. The accessories are sold separately.
The provided text is a 510(k) summary for the Medtronic Octopus® TE Stabilizer & Accessories, which is a cardiovascular surgical instrument. It outlines the device's description, intended use, and substantial equivalence to predicate devices. However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as it would apply to a diagnostic or AI-driven medical device.
This 510(k) pertains to a physical surgical instrument, not a device that generates data or requires performance metrics like sensitivity, specificity, or accuracy. The assessment of such a device focuses on "substantial equivalence" to legally marketed predicate devices in terms of design, materials, manufacturing processes, and intended use, rather than a clinical performance study with statistical endpoints.
Therefore, most of the requested information (acceptance criteria, device performance table, sample sizes, data provenance, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types and establishment) is not applicable to this type of regulatory submission and is not present in the provided text.
Here's a breakdown of why the information is not present based on the nature of the device:
- 1. A table of acceptance criteria and the reported device performance: Not applicable. Performance for a surgical instrument is assessed through comparisons of its technological characteristics (e.g., design, materials, principle of operation) to predicate devices, and potentially through bench testing for safety and functional specifications, not a performance table against clinical acceptance criteria as would be seen for a diagnostic or AI device.
- 2. Sample sized used for the test set and the data provenance: Not applicable. There is no "test set" in the context of clinical performance data for this type of surgical instrument in this document.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert review process of clinical data is described in this 510(k) summary for the device's performance.
- 4. Adjudication method for the test set: Not applicable.
- 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 is not an AI-assisted diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable. This is not a machine learning device.
- 9. How the ground truth for the training set was established: Not applicable.
Summary of Relevant Information from the Document:
- Device Type: Cardiovascular Surgical Instrument/Heart Stabilizer.
- Regulatory Pathway: 510(k) Premarket Notification, indicating substantial equivalence to predicate devices.
- Predicate Devices: Medtronic Octopus Tissue Stabilizer (K964445) and the CTS (Guidant) Vacuum Assist Stabilizer (K992833).
- Basis of Equivalence: Patient population, intended use, function, basic system components, device design, and principal of operation were found to be substantially equivalent to the predicate devices.
- Study Described: The document refers to "Comparisons between the new and predicate devices shows that technological characteristics (i.e. device design and principal of operation) are substantially equivalent." This implies an engineering and design comparison rather than a clinical study with performance metrics in the typical sense.
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JUL 1 9 2004
510(k) Summary
: -
| Submitter: | Medtronic Cardiac Surgery Technologies7601 Northland DriveMinneapolis, MN 55428 |
|---|---|
| Contact: | Scott Cundy |
| Telephone: (763) 391-9941Fax: (763) 391-9279 | |
| Date Prepared: | 18 May 2004 |
| Trade Name: | Medtronic Octopus® TE Stabilizer & Accessories |
| Common Name: | Cardiovascular Surgical Instrument/Heart Stabilizer |
| Equivalence to: | The Medtronic Octopus TE Stabilizer & Accessories aresubstantially equivalent in patient population, intended use,function and basic system components to the Medtronic OctopusTissue Stabilizer (K964445) and the CTS (Guidant) VacuumAssist Stabilizer (K992833). |
| The Medtronic Octopus TE Stabilizer has an optional irrigator(lavage) that is designed to provide drip irrigation for improvedvisibility. Said irrigator has a similar surgical site cleansingindication for use as existing jet lavage systems such as theMedtronic Clearview Blower/Misted (K973485). | |
| Description: | The non-sterile, reusable Medtronic Octopus TE Heart StabilizingSystem is a suction-based tissue stabilizer with a collapsible podassembly, a rigid shaft and 5 articulating links designed to enabletransfer into the thoracic cavity via a 12 mm thoracic port ortraditional sternotomy access. It is comprised of four distinctelements: (1) the Medtronic Octopus TE Tissue Stabilizer, (2) theMedtronic Octopus TE Suction Lines, (3) the Medtronic OctopusTE Vacuum Lines, and (4) the Medtronic Octopus TE Irrigator(optional). |
| The Medtronic Octopus TE Heart Stabilizer is secured to a flexiblearm and universal mounting rail, which attached to the operatingtable rail. Vacuum is delivered to the pod assembly by adisposable suction line inserted through the shaft of the stabilizerand a disposable vacuum line that connects the stabilizer to thevacuum source. The accessories are sold separately. | |
| Intended Use: | The Medtronic Octopus TE Stabilizer is used to stabilize theepicardial surface of the non-arrested heart during coronary arterysurgery. It is intended to be used by trained medical professionalsin operating room environments. |
| TechnologicalCharacteristics: | Comparisons between the new and predicate devices shows thattechnological characteristics (i.e. device design and principal ofoperation) are substantially equivalent. |
| Conclusion: | The Medtronic Octopus TE Stabilizer was found to besubstantially equivalent in patient population, intended use,principal of operation and basic system components to thepredicate devices. |
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2004
Medtronic Cardiac Surgery Technologies c/o Davis D. Cox, Ph.D. Principal Regulatory Affairs Specialist 7601 Northland Drive Minneapolis, MN 55428-1088
Re: K041338
Octopus TE Tissue Stabilizer Regulation Number: 21 CFR 870.4500 Regulation Name: Cardiovascular Surgical Instruments Regulatory Class: Class I (one) Product Code: MWS Dated: July 8, 2004 Received: July 9, 2004
Dear Dr. Cox:
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.
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Page 2 - Davis D. Cox, Ph.D.
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 Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dvina R. buchanan
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K041338
Octopus TE Tissue Stabilizer Device Name:
Indications for Use:
The Stabilizer is intended to stabilize the epicardial surface of the nonarrested heart during coronary artery surgery. It is intended to be used only by medical professionals in operating room environments.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
のお気になる。
R. Vochner
)ivision Sign-Off) ision of Cardiovascular Devices
) Number K041338
§ 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.