(35 days)
Not Found
Not Found
No
The device description and intended use focus on mechanical retraction and dissection, with no mention of AI/ML capabilities or data processing.
No
The device is described as a retractor used for dissection and retraction of tissue to create and maintain an operative cavity during surgical procedures. Its function is to assist in surgery, not to directly treat a disease or condition.
No
Explanation: The device description states its application is for creating and maintaining an operative cavity for surgical procedures requiring dissection and retraction of tissue, indicating it is an surgical retration and disecction device, and not a diagnostic device.
No
The device description clearly describes a physical, single-patient use retractor with a blunt tip, shaft, and transparent tip, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical tool used for creating and maintaining operative cavities and dissecting/retracting tissue within the body. This is an in-vivo application.
- Device Description: The description details a physical retractor used for surgical procedures, including dissection and retraction of soft tissue. This is a surgical instrument, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CardioVations Retractor does not fit this description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extraperitoneal spaces such as the retroperitoneal, preperitoneal, and subcutaneous areas.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Results of verification testing indicates that the product meets the established performance requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
CardioVations Ultra-Retractor
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) SUMMARY K031847
| Statement | Information supporting claims of substantial equivalence, as
defined under the Federal Food, Drug, and Cosmetic Act,
respecting safety and effectiveness is summarized below. For the
convenience of the Reviewer, this summary is formatted in
accordance with the Agency's final rule ".... 510(k) Summaries
and 510(k) Statements ...." (21 CFR 807) and can be used to
provide a substantial equivalence summary to anyone requesting it
from the Agency. | | |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|--|
| | MODIFIED DEVICE NAME: | CardioVations Retractor | |
| | PREDICATE DEVICE NAME: | CardioVations Ultra-
Retractor | |
| Device Description | 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). | | |
| Intended 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. | | |
1
| Indications Statement | 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. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | The modified device has the same technological characteristics as
the predicate device. The form, fit, function and method of
operation are similar. |
| Performance Data | Results of verification testing indicates that the product meets the
established performance requirements. |
| Conclusion | Based upon the 510(k) summaries and 510(k) statements (21 CFR
807) and the information provided herein, we conclude that the
subject device is substantially equivalent to the predicate devices
under the Federal Food, Drug and Cosmetic Act. |
| Contact | Peter Cecchini
Manager
Regulatory Affairs
ETHICON, Inc.
Rt. 22 West
Somerville, NJ 08876-0151 |
| Date | June 13, 2003 |
2
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.
3
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
4
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 |
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