(58 days)
Not Found
No
The description focuses on mechanical articulation and a simple light source, with no mention of AI/ML terms or functionalities.
No
Explanation: The device is intended to dissect soft tissue and provide illumination for navigation during surgical procedures, which are functions of a surgical instrument rather than a therapeutic device that treats or cures a disease or condition. Its purpose is to aid in the surgical process, not to deliver a therapy.
No
The AtriCure Dissector is intended to dissect soft tissue and features a light source for navigation and identification of anatomic structures during surgical procedures. Its primary function is surgical intervention (dissection), not diagnosis of a disease or condition. The identification of structures is for surgical navigation, not for making a diagnosis.
No
The device description clearly states it is a hand-held, single-use surgical articulated dissector with an integral light source, indicating it is a physical hardware device.
Based on the provided information, the AtriCure Dissector™ is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for dissecting soft tissue during surgical procedures. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The description details a surgical tool used for physical manipulation of tissue, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue samples, or any other biological material for diagnostic purposes. The light source is for navigation during surgery, not for analyzing samples.
Therefore, the AtriCure Dissector™ is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AtriCure 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.
Product codes
FTD, GDI
Device Description
The AtriCure Dissector™ is a hand held, single use, surgical articulated dissector with intearal light source intended to for use by qualified surgeons only. The surgeon is able to articulate the distal member of the device by means of hand actuated rotation knob. The surgeon directly controls the amount of articulation and tissue dissection. A small light source is attached to the distal tip of the articulation member, which remains illuminated for a minimum of four (4) hours. Multiple models of the Dissector™ are available with varving shaft lengths to accommodate surgeon preference and differing patient habitus.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons
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)
Appropriate product testing was conducted according to the Design Control requirements as defined in 21 CFR 820.30 to evaluate conformance to product specification and substantial equivalence to the legally marketed device. These activities included Risk Analysis, Process Verification, and Biocompatibility Testing. Biocompatibility testing was conducted according to ISO 10993-1 to confirm that the modified Dissector™ is safe for limited use (
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
0
K///.020
ATRICURE DISSECTOR™ 510(k) SUMMARY
General Information
| Date Compiled | April 11, 2011 |
|---|---|
| Classification | Class II (Surgical Lamp) |
| 21 CFR 878.4580 | |
| Product Code | FTD, GDI |
| Trade Name | AtriCure DissectorTM |
| Manufacturer | AtriCure, Inc |
| 6217 Centre Park Drive | |
| West Chester, OH 45069 | |
| Contact | James L. Lucky |
| VP of Quality Assurance and Regulatory Affairs | |
| (513) 755-5754 |
Indications for Use
The AtriCure 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.
Cleared Device
The device proposed for modification in this submission is the AtriCure Dissector™ (K041681).
Device Description
The AtriCure Dissector™ is a hand held, single use, surgical articulated dissector with intearal light source intended to for use by qualified surgeons only. The surgeon is able to articulate the distal member of the device by means of hand actuated rotation knob. The surgeon directly controls the amount of articulation and tissue dissection. A small light source is attached to the distal tip of the articulation member, which remains illuminated for a minimum of four (4) hours. Multiple models of the Dissector™ are available with varving shaft lengths to accommodate surgeon preference and differing patient habitus.
Materials
All materials used in the manufacture of the AtriCure Dissector™ are suitable for their intended use and have been used in numerous previously cleared products. Materials used include, but are not limited to, medical grade silicone, stainless steel, medical grade adhesive, and acrylic epoxy resin. Testing was conducted in Accordance with ISO 10993-1 to ensure appropriate biocompatibility of all materials.
Testing
Appropriate product testing was conducted according to the Design Control requirements as defined in 21 CFR 820.30 to evaluate conformance to product specification and substantial equivalence to the legally marketed device. These activities included Risk
1/2
1
Analysis, Process Verification, and Biocompatibility Testing. Biocompatibility testing was conducted according to ISO 10993-1 to confirm that the modified Dissector™ is safe for limited use ( Sincerely yours. Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
KII/020 510(k) Number (if known):
Device Name: AtriCure Dissector™
Indications For Use:
The AtriCure 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.
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)
Neil R.P. Ogden for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number.