(79 days)
Heart Stabilizers and Positioners are devices that are designed to stabilize, move, lift, and position the heart during cardiovascular surgery. Tissue Stabilizers are designed to stabilize and minimize the movement of localized areas of a beating heart during offpump cardiac surgery. Tissue Positioners are designed to lift and hold the heart in position during cardiac surgery.
Heart Stabilizers are retractor-based devices that consist of two tissue stabilizers attached to an articulating arm. The ends of the tissue stabilizers are spaced about 8 to 15 mm apart, nominally. The articulating arm fastens to a retractor by use of a mounting clamp. The arm is tightened and loosened by a large knob on the proximal end. As the arm tightens, the tissue stabilizers spread a minimum of 3 mm in an arc fashion. Each slightly curved tissue stabilizer is composed of four suction pods. With the pods placed on either side of the anastamosis site, suction is applied to stabilize the tissue.. A stopcock provides control of suction.
Heart Positioners are designed to be used in conjunction with the Tissue Stabilizer to facilitate access to and enhance exposure of the coronary arteries for coronary artery bypass procedures. The device is retractor-based and incorporates a silicone suction apparatus, an articulating arm and a mounting clamp. The silicone apparatus is attached to the surface of the heart by the application of regulated vacuum. The mounting clamp has been designed to be compatible with most adult median sternotomy retractors.
This submission is for reprocessed heart stabilizers and positioners, and the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full study with acceptance criteria and detailed performance data like a clinical trial for a novel device.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or cannot be extracted from this type of regulatory document. The focus here is on functional and safety testing to show the reprocessed device performs as intended and is equivalent to the original.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device must perform its intended function (stabilize, move, lift, and position the heart) as effectively as the predicate device. | "Representative samples of reprocessed heart stabilizers and positioners underwent functional testing to demonstrate appropriate functional characteristics." (No specific metrics or quantitative results provided) |
| Cleaning Procedures Validation: Reprocessing must effectively clean the devices. | "Process validation testing was done to validate the cleaning... procedures." (No specific metrics or validation methods detailed) |
| Sterilization Procedures Validation: Reprocessing must effectively sterilize the devices. | "Process validation testing was done to validate the... sterilization procedures." (No specific metrics or validation methods detailed) |
| Packaging Validation: Reprocessing must ensure proper packaging for sterility and integrity. | "Process validation testing was done to validate the... device packaging." (No specific metrics or validation methods detailed) |
| Visual and Functional Inspection: All reprocessed products must pass visual and functional checks. | "In addition, the manufacturing process includes visual and functional testing of all products produced." (No specific failure rates or inspection criteria provided) |
| Substantial Equivalence: The reprocessed device must be substantially equivalent to the predicate device in functional design, materials, indications for use, and methods of construction. | "The reprocessed heart stabilizers and positioners are substantially equivalent to the Medtronic Octopus Tissue Stabilizer (and Positioner) (K964445)... This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "representative samples" for functional testing and "all products produced" for manufacturing process testing, but no specific number of devices or tests.
- Data Provenance: Not specified, but generally, such testing would be conducted internally by SterilMed, Inc. It is retrospective in the sense that it's testing on devices that have undergone reprocessing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This is not applicable to a 510(k) for a reprocessed medical device. The "ground truth" here is the original device's performance characteristics, and the reprocessing is validated against maintaining those characteristics, not against expert interpretation of data.
4. Adjudication Method for the Test Set
- Not applicable. This is not a study involving human readers or expert adjudication of ambiguous cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically for AI-assisted diagnostic devices, which is not the nature of this reprocessed instrument.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
- Not applicable. This device is a reprocessed physical instrument, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" used for this submission is the performance specifications and characteristics of the original, new Medtronic Octopus Tissue Stabilizer (and Positioner) (K964445). The reprocessing process and the reprocessed devices are validated to ensure they meet these established specifications, effectively performing identically to the new device.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI-based device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set.
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STERILMED, INC.
Medical Device Reprocessing
Small Equipment & Instrument Repair
For Reprocessed Heart Stabilizers And Positioners
MAR 1 5 2007
II. SUMMARY AND CERTIFICATION
510(k) Summary A.
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Dennis Toussaint11400 73rd Avenue NorthMaple Grove, MN 55369Ph: 888-856-4870Fax: 763-488-3350 |
| Date Prepared: | December 22, 2006 | |
|---|---|---|
| Trade Name: | Reprocessed Heart Stabilizers and Positioners | |
| Classification Name: | Cardiovascular Surgical Instruments | |
| Classification Number: | Class I, 21 CFR 870.4500 | |
| Product Code: | NQG |
| PredicateDevices: | The reprocessed heart stabilizers and positioners are substantially equivalent to theMedtronic Octopus Tissue Stabilizer (and positioner) (K964445). The non-reprocessed heart stabilizers and positioners are Class I, 510(k) exempt devices. |
|---|---|
| DeviceDescription: | Heart Stabilizers are retractor-based devices that consist of two tissue stabilizersattached to an articulating arm. The ends of the tissue stabilizers are spaced about 8 to15 mm apart, nominally. The articulating arm fastens to a retractor by use of amounting clamp. The arm is tightened and loosened by a large knob on the proximalend. As the arm tightens, the tissue stabilizers spread a minimum of 3 mm in an arcfashion. Each slightly curved tissue stabilizer is composed of four suction pods. Withthe pods placed on either side of the anastamosis site, suction is applied to stabilize thetissue.. A stopcock provides control of suction. |
| Heart Positioners are designed to be used in conjunction with the Tissue Stabilizer tofacilitate access to and enhance exposure of the coronary arteries for coronary arterybypass procedures. The device is retractor-based and incorporates a silicone suctionapparatus, an articulating arm and a mounting clamp. The silicone apparatus isattached to the surface of the heart by the application of regulated vacuum. Themounting clamp has been designed to be compatible with most adult mediansternotomy retractors. | |
| Intended Use: | Heart Stabilizers and Positioners are devices that are designed to stabilize, move, lift,and position the heart during cardiovascular surgery. |
| Functional andSafety Testing: | Representative samples of reprocessed heart stabilizers and positioners underwentfunctional testing to demonstrate appropriate functional characteristics. Processvalidation testing was done to validate the cleaning and sterilization procedures as wellas device packaging. In addition, the manufacturing process includes visual andfunctional testing of all products produced. |
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For Reprocessed Heart Stabilizers And Positioners
| Conclusion: | The reprocessed heart stabilizers and positioners are substantially equivalent to the Octopus Tissue Stabilizer (and Positioner) (K964445) manufactured by Medtronic. This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction. |
|---|---|
| -------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
. . . .
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol featuring a staff with two snakes coiled around it, topped by wings. The caduceus is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".
MAR 1 5 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SterilMed Inc. c/o Mr. Dennis Toussaint Director of Regulatory Affairs 11400 73td Avenue North Maple Grove, MN 55369
Re: K063844
Octopus 3.0, 4.0, and 4.3 Stabilizers, Starfish 2 Positioner, and Urchin Positioner Regulation Number: 21 CFR 870.4500 Regulation Name: Cardiovascular Surgical Instruments Regulatory Class: Class I Product Code: NOG Dated: February 23, 2007 Received: February 26, 2007
Dear Mr. Toussaint:
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 - Mr. Dennis Toussaint
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 (240) 276-0120. 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 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,
ina R. Luchtner
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): K063844
Device Name: Reprocessed Heart Stabilizers and Positioners
Indications For Use:
Heart Stabilizers and Positioners are devices that are designed to stabilize, move, lift, and position the heart during cardiovascular surgery. Tissue Stabilizers are designed to stabilize and minimize the movement of localized areas of a beating heart during offpump cardiac surgery. Tissue Positioners are designed to lift and hold the heart in position during cardiac surgery.
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)
Duna R. Jahner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) number K063844
Page 1 of 1
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| ProCode | Family | Model |
|---|---|---|
| NQG | Medtronic HeartStabilizers andPositioners | Octopus 3.0 Stabilizer |
| Octopus 4.0 Stabilizer | ||
| Octopus 4.3 Stabilizer | ||
| Starfish 2 Positioner | ||
| Urchin Positioner |
§ 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.