(28 days)
Not Found
No
The summary describes a mechanical tissue dissection device with a light source for navigation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on mechanical characteristics and electrical safety, not algorithmic performance.
No
The device is intended to dissect soft tissue during surgical procedures, not to treat a specific medical condition or disease.
No
The device is described as a "Tissue Dissection Device" intended to "dissect soft tissue" and has a light source for navigation. Its function is to cut and separate tissue, not to diagnose conditions.
No
The device description explicitly states it is a "single-use, hand-held surgical tissue dissector with an integral light source," indicating it is a physical hardware device, not software only.
Based on the provided information, the Medtronic® Cardioblate® Navigator™ Tissue Dissection Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "dissecting soft tissue during general, ENT, thoracic, urological, and gynecological surgical procedures." This describes a surgical tool used in vivo (within the body) for physical manipulation of tissue.
- Device Description: The description reinforces this by calling it a "single-use, hand-held surgical tissue dissector."
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with patient specimens outside the body.
Therefore, the device is a surgical instrument used during procedures on a patient, not an IVD.
N/A
Intended Use / Indications for Use
The Medtronic® Cardioblate® Navigator™ Tissue Dissection Device is intended to dissect soft tissue during general, ENT, thoracic, urological, and gynecological surgical procedures. The device's battery-powered light source is used to navigate soft tissue for identification of the tip location around anatomic structures.
Product codes (comma separated list FDA assigned to the subject device)
FTD, GCJ
Device Description
The Medtronic Navigator tissue dissection device is a single-use, hand-held surgical tissue dissector with an integral light source.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, anatomic structures.
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)
Verification and validation testing confirms that functional characteristics are substantially equivalent to the predicate device cited. This included clip strength and clip deployment angle. All test data obtained satisfied the documented product and performance specifications. In addition, the device meets the requirements for Medical Electrical Equipment: General Requirements (IEC 60601-1).
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.
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
Cardioblate® Navigator™
1 2006
510(k) SUMMARY of Safety and Effectiveness
l. Applicant Information:
| Date Prepared: | August 19, 2006 | |
|---|---|---|
| Submitter: | Medtronic, Inc. | OCT |
| Address: | 710 Medtronic Parkway, NE | |
| Minneapolis, MN 55432-5604 | ||
| Establishment | ||
| Registration No. | 2135394 | |
| Contact Person: | Scott Cundy | |
| Senior Director – Regulatory & Clinical Affairs | ||
| Telephone Number: | (763) 391-9941 | |
| Fax Number: | (763) 391-9279 |
II. Device Information:
| Trade Name: | Cardioblate Navigator™ |
|---|---|
| Common Name: | Tissue Dissection Device |
| Classification Name: | Lamp, Surgical |
|---|---|
| Classification: | Class II, 21 CFR 878.4580 |
| Product Code: | FTD |
Predicate Device: AtriCure® Wolf dissector™ 510(k) No. K041681, Reg. No. 878.4580; Product Code: FTD
Device Intended Use: The AtriCure Wolf dissector™ is intended to dissect soft tissue during general, ENT, thoracic, urological, and gynecological surgical procedures. The Dissector's battery-powered light source is used to navigate soft tissue for identification of anatomic structures.
:
1
Cardioblate® Navigator™
- The Medtronic Navigator tissue dissection device is a single-Device Description: use, hand-held surgical tissue dissector with an integral light source.
- The Medtronic® Cardioblate® Navigator™ Tissue Dissection Intended Use: Device is intended to dissect soft tissue during general, ENT, thoracic, urological, and gynecological surgical procedures. The device's battery-powered light source is used to navigate soft tissue for identification of the tip location around anatomic structures.
- Contraindications: None.
Comparison to
- Predicate Device(s): The Cardioblate® Navigator" device is substantially equivalent to the AtriCure Wolf dissector™, cleared in K041681, in terms of materials, use and application. The two devices are both hand held surgical dissectors with articulating tips and an integral light source (LED) for use in visually identifying internal tissue structures.
- Verification and validation testing confirms that functional Test Data: characteristics are substantially equivalent to the predicate device cited. This included clip strength and clip deployment angle. All test data obtained satisfied the documented product and performance specifications. In addition, the device meets the requirements for Medical Electrical Equipment: General Requirements (IEC 60601-1).
- Summary: Based upon the technical information, intended use, in vitro, in vivo, and clinical performance information provided in previous pre-market notifications, the Cardioblate® Navigator" described in this submission has been shown to be substantially equivalent to the currently marketed predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized representation of a human figure, with three abstract shapes forming the head and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 1 2006
Medtronic. Inc. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street. NW Buffalo, Minnesota 55313
Re: K062727
Trade/Device Name: Medtronic Cardioblate® Navigator Tissue Dissection Device, Model 68015 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: September 29, 2006 Received: October 2, 2006
Dear Mr. Job:
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. Mark Job
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and in your of substantial equivalence of your device to a legally premaince nedicate 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 In Jun the Office of Compliance at (240) 276-0115. 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 vours,
Ron Duly
Mark N. Melkersen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
K062727 510(k) Number:
Device Name: Medtronic Cardioblate® Navigator Tissue Dissection Device, Model 68015
Indications for use:
The Medtronic® Cardioblate® Navigator™ Tissue Dissection Device is intended to dissect soft tissue during general, ENT, thoracic, urological, and gynecological surgical procedures. The device's battery-powered light source is used to navigate soft tissue for identification of the tip location around anatomic structures.
Prescription Use 区 (Part 21 CFR 801 Subpart D)
OR Over-The-Counter-Use (Part 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)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Medtronic Cardioblate® 68000 Generator く1/1/k)Premarket Notification
0627
Section 4 - Page 1
510(k) Number