(35 days)
The CardioVations Retractor has application for use in the creation and maintenance of an operative cavity in the extraperitoneal spaces such as the retroperitoneal, preperitoneal and subcutaneous areas. The device may be used in surgical procedures requiring dissection and retraction of tissue.
The CardioVations Retractor is a single patient use device for dissection and retraction of soft tissue to maintain space while under endoscope visualization. For example, like the predicate device, the retractor will be used to dissect and retract tissue surrounding a vessel to allow for instrument passage beneath the shaft of the retractor in vessel harvesting procedures. The blunt, spoon (hood) distal tip functions to dissect and create a working cavity for instrument passage. The wide shaft provides for retraction and maintenance of the operative working space. The transparent tip allows visualization during insertion, tunneling and dissection. A vein retractor feature has been added. The device is compatible with the CardioVations Optical Bipolar Device (included in the vessel harvesting package tray).
This document describes a 510(k) submission for the CardioVations Retractor, a medical device for tissue dissection and retraction. The submission focuses on demonstrating substantial equivalence to a predicate device, the CardioVations Ultra-Retractor, rather than presenting a detailed study with specific acceptance criteria and performance metrics typically seen for AI/ML-based devices.
Therefore, many of the requested sections are not applicable or cannot be extracted from the provided text.
Here is an attempt to address the points based on the available information, noting where information is absent:
1. A table of acceptance criteria and the reported device performance
The provided text does not specify numerical acceptance criteria or detailed quantitative performance metrics for the CardioVations Retractor. The submission states: "Results of verification testing indicates that the product meets the established performance requirements." However, what those established performance requirements are (e.g., force limits, dissection speed, tissue damage scores) and the specific results of the verification testing are not detailed.
Being a physical retractor device, the "performance" here relates to its mechanical and functional integrity to perform its intended surgical tasks safely and effectively.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The submission refers to "verification testing" but does not detail the sample size, type of testing (e.g., benchtop, animal, human cadaver), or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. For a physical surgical retractor, "ground truth" as it applies to AI/ML or diagnostic devices is not relevant. The performance evaluation would likely involve engineering tests, biocompatibility tests, and potentially simulated use or animal studies, where expert opinion might guide the study but not establish a "ground truth" in the same way.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in studies involving subjective interpretation (e.g., image reading) where multiple experts assess the same data. This is not relevant for a mechanical device like a retractor.
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
This information is not applicable. An MRMC study is relevant for diagnostic devices, particularly those involving human interpretation of data (e.g., radiographs, pathology slides), often with AI assistance. The CardioVations Retractor is a surgical tool, not a diagnostic or AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This question is pertinent to AI/ML devices. The CardioVations Retractor is a mechanical surgical tool.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable in the traditional sense for a physical medical device. The "ground truth" for a surgical retractor is its ability to mechanically dissect and retract tissue as intended without causing undue harm or failing during use. This is typically assessed through engineering specifications, biocompatibility, sterilization validation, and potentially simulated or animal use studies. The document does not specify these methods in detail.
8. The sample size for the training set
This information is not applicable. Training sets are used for AI/ML algorithms, which are not involved in this device.
9. How the ground truth for the training set was established
This information is not applicable. Training sets and their associated ground truth are relevant for AI/ML algorithms, which are not involved in this device.
Summary of the Study (Based on Substantial Equivalence Claim):
The provided 510(k) summary for the CardioVations Retractor indicates that the device's acceptance criteria and proof of meeting them are primarily based on demonstrating substantial equivalence to a predicate device, the CardioVations Ultra-Retractor.
- Acceptance Criteria (Implied): The implied acceptance criteria are that the modified device (CardioVations Retractor) performs its intended functions safely and effectively, and is as safe and effective as its predicate device. This is supported by the statement "Results of verification testing indicates that the product meets the established performance requirements."
- Study That Proves the Device Meets the Criteria: The "study" is the overall 510(k) submission itself, where the manufacturer provides evidence of substantial equivalence. This includes:
- Device Description: Highlighting that the CardioVations Retractor is a single patient use device for dissection and retraction of soft tissue, similar to the predicate. It notes the addition of a "vein retractor feature."
- Intended Use/Indications for Use: Stating that the device is for creating and maintaining operative cavities in extraperitoneal spaces, requiring tissue dissection and retraction, which is identical to the listed predicate's use.
- Technological Characteristics Comparison: Explicitly stating, "The modified device has the same technological characteristics as the predicate device. The form, fit, function and method of operation are similar." This is a crucial element in demonstrating substantial equivalence.
- Performance Data: A general statement confirms: "Results of verification testing indicates that the product meets the established performance requirements." While specific data is not included in this summary, the FDA review would have relied on this data to make its determination. This "verification testing" would likely include mechanical performance tests, material compatibility, sterilization validation, and other bench-top or simulated use tests relevant to a physical surgical instrument.
Conclusion from the Document:
The FDA's decision to clear the device (K031847) confirms that, based on the provided information, they determined the CardioVations Retractor to be substantially equivalent to the predicate device. This means the FDA found the device to be as safe and effective as a legally marketed device that does not require premarket approval.
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510(k) SUMMARY K031847
| Statement | Information supporting claims of substantial equivalence, asdefined under the Federal Food, Drug, and Cosmetic Act,respecting safety and effectiveness is summarized below. For theconvenience of the Reviewer, this summary is formatted inaccordance with the Agency's final rule ".... 510(k) Summariesand 510(k) Statements ...." (21 CFR 807) and can be used toprovide a substantial equivalence summary to anyone requesting itfrom the Agency. | ||
|---|---|---|---|
| MODIFIED DEVICE NAME: | CardioVations Retractor | ||
| PREDICATE DEVICE NAME: | CardioVations Ultra-Retractor | ||
| Device Description | The CardioVations Retractor is a single patient use devicefor dissection and retraction of soft tissue to maintain space whileunder endoscope visualization. For example, like the predicatedevice, the retractor will be used to dissect and retract tissuesurrounding a vessel to allow for instrument passage beneath theshaft of the retractor in vessel harvesting procedures. The blunt,spoon (hood) distal tip functions to dissect and create a workingcavity for instrument passage. The wide shaft provides forretraction and maintenance of the operative working space. Thetransparent tip allows visualization during insertion, tunneling anddissection. A vein retractor feature has been added. The device iscompatible with the CardioVations Optical Bipolar Device(included in the vessel harvesting package tray). | ||
| Intended Use | The CardioVations Retractor has application for use in the creationand maintenance of an operative cavity in the extraperitonealspaces such as the retroperitoneal, preperitoneal, and subcutaneousareas. The device may be used in surgical procedures requiringdissection and retraction of tissue. |
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| Indications Statement | The CardioVations Retractor has application for use in the creationand maintenance of an operative cavity in the extraperitonealspaces such as the retroperitoneal, preperitoneal and subcutaneousareas. The device may be used in surgical procedures requiringdissection and retraction of tissue. |
|---|---|
| TechnologicalCharacteristics | The modified device has the same technological characteristics asthe predicate device. The form, fit, function and method ofoperation are similar. |
| Performance Data | Results of verification testing indicates that the product meets theestablished performance requirements. |
| Conclusion | Based upon the 510(k) summaries and 510(k) statements (21 CFR807) and the information provided herein, we conclude that thesubject device is substantially equivalent to the predicate devicesunder the Federal Food, Drug and Cosmetic Act. |
| Contact | Peter CecchiniManagerRegulatory AffairsETHICON, Inc.Rt. 22 WestSomerville, NJ 08876-0151 |
| Date | June 13, 2003 |
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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above them that resemble wings or feathers.
JUL 2 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Peter Cecchini Manager, Regulatory Affairs Ethicon, Inc. Route 22 West Somerville, New Jersey 08876-0151
Re: K031847
Trade/Device Name: CardioVations Retractor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: June 13, 2003 Received: June 26, 2003
Dear Mr. Cecchini :
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.
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.
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Page 2 - Mr. Peter Cecchini
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) 594-4659. 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,
Miriam C. Provost
(Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
| 510(k) Number (if known): | K031847 |
|---|---|
| Device Name: | CardioVations Retractor |
| Indications for Use: | The CardioVations Retractor has application for use in the creation and maintenance of an operative cavity in the extraperitoneal spaces such as the retroperitoneal, preperitoneal and subcutaneous areas. The device may be used in surgical procedures requiring dissection and retraction of tissue. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---|---|
| --------------------------------------- | -------------- |
OR
Over-The Counter Use
(Optional Format 1-2-9G)
| Miriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices | |
|---|---|
| CardioVations Retractor ETHICON, Inc. | |
| 510(k) Number. | K031847 |
iii
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.