(94 days)
Not Found
No
The device description focuses on the physical components and electrical connection for tissue coagulation, with no mention of AI or ML.
Yes
The device is used to coagulate soft tissue during surgical procedures, which is a therapeutic function.
No
Explanation: The device is intended to coagulate soft tissue during surgical procedures, which is a therapeutic function, not a diagnostic one. It does not gather information about a patient's health condition to aid in diagnosis.
No
The device description clearly states it is a "stainless Steel tube covered with an insulation material" and is intended to fit over a tissue removal blade, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "coagulate soft tissue during various spinal surgical procedures." This is a direct surgical intervention on a patient's body.
- Device Description: The device is a surgical tool (a sheath) used in conjunction with a generator to apply energy for tissue coagulation.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Endius Bipolar Sheath is intended to be used to coagulate soft tissue during various spinal surgical procedures.
Product codes
GEI
Device Description
The Endius Bipolar Sheath is a stainless Steel tube covered with an insulation material that is intended to fit over an automated tissue removal blade. The device is intended to be connected to the Valley Lab's Force 2 generator by using the Bipolar Sheath Adapter which is intended to decrease the maximum voltage of the Valley Lab's Generator from 800 volts to 100 volts. This will ensure that the appropriate level of energy is transmitted to the Bipolar Sheath for the maximum performance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue during various spinal surgical procedures.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
MAR 2 2 2001
Section 7- 510(k) Summary of Safety and Effectiveness
| 7.1
Statement | This summary of 510(k) safety and effectiveness information is being submitted
in accordance with the requirements of SMDA 1990 and CFR 807.92 |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7.2
Submitter | Endius, Inc.
23 West Bacon Street
Plainville, MA. 02762 |
| 7.3
Company
Contact | Susan Finneran
Director Regulatory Affairs
508-643-0983 |
| 7.4
Device Name | Proprietary Name: Endius Bipolar Sheath
Common Name: Bipolar Coagulation Device
Classification Name: Electrosurgical cutting and coagulation device and
accessories |
| 7.5
Predicate
Legally
Marketed
Devices | The Bipolar Sheath is substantially equivalent to the Everest Bipolar Probes,
Everest Medical (Minneapolis, MN). |
| 7.6
Device
Description | The Endius Bipolar Sheath is a stainless Steel tube covered with an insulation
material that is intended to fit over an automated tissue removal blade. The
device is intended to be connected to the Valley Lab's Force 2 generator by
using the Bipolar Sheath Adapter which is intended to decrease the maximum
voltage of the Valley Lab's Generator from 800 volts to 100 volts. This will
ensure that the appropriate level of energy is transmitted to the Bipolar Sheath
for the maximum performance. |
| 7.8 | The Endius Bipolar Sheath is substantially equivalent to the Everest Bipolar |
| Substantial | Forceps |
| Equivalence | |
1
7.7 The Endius Bipolar Sheath is intended to be used in conjunction with the Device The Endius Diponal Biload Risan Rostem to cut and coagulate soft tissue during Indications and Intended use various spinal surgical procedures.
| Table of Substantial Equivalence | ||
|---|---|---|
| Device Name | Everest Bipolar Forcep | Endius Bipolar Sheath and MDS |
| Device | ||
| 510k # | K945975 | The subject of this submission |
| Intended use | The Everest Bipolar Forceps | |
| are intended to be used to cut | ||
| and coagulate soft tissue | ||
| electrosurgically. | The Endius Bipolar Sheath is | |
| intended to be used in conjunction | ||
| with the Endius XPS | ||
| Microdebrider System to cut and | ||
| coagulate soft tissue during | ||
| various spinal surgical procedures. | ||
| Materials | Stainless Steel, Plastics, | |
| Adhesives, and ceramics | Stainless Steel, Parylene coating, | |
| plastics, adhesives | ||
| Sterilization/ | ||
| Labeling | Single Use, Sterilized by | |
| Ethylene Oxide | Single use, Sterilized by gamma | |
| irradiation | ||
| Sizes | 3mm and 5mm | 4.5mm |
Applicant
Date 12/15/00
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three swooping lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2001
Ms. Susan Finneran Director Regulatory Affairs/Clinical Sciences Endius. Incorporated 23 West Bacon Street Plainville, Massachusetts 02762
Re: K003897
Trade Name: Endius Bipolar Sheath and Accessories Regulatory Class: II Product Code: GEI Dated: February 6, 2001 Received: February 7, 2001
Dear Ms. Finneran:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Susan Finneran
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Miriam C. Provost
for 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
510(k) Number (if known): K003897
Device Name: Endius Bipolar Sheath and Accessories
Indications for Use: The Endius Bipolar Sheath is intended to be used to coagulate soft tissue during various spinal surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) מילות מיני נושב על המיני במונח במ
Concurence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
(Posted July 1, 1998)
iriam C. Provost
(Division Sign-Off) (Division Sigi-Oral, Restorative Division of Neurological Devices
K003897 510(k) Number -
L
Prescription Use _ (Per 21 CFR 801.109)