(27 days)
Not Found
No
The description focuses on the physical components and electrical connection for tissue coagulation, with no mention of AI/ML terms or functions.
Yes
The device is intended to be used in surgical procedures to coagulate soft tissue, which is a therapeutic action aimed at treating or preventing bleeding.
No
The device is described as being used to "coagulate soft tissue," which is a therapeutic function, not a diagnostic one. It fits over a tissue removal blade and transmits energy for performance, further indicating a treatment role rather than a diagnostic role.
No
The device description clearly states it is a stainless steel tube with insulation, intended to fit over a tissue removal blade and connect to a generator. This describes a physical hardware device, not software.
Based on the provided information, 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 describes a surgical tool used directly on a patient's tissue in vivo (within the living body).
- Device Description: The description details a surgical instrument (a stainless steel tube with insulation) designed to be used with a generator to deliver energy for tissue coagulation. This is consistent with a surgical device, not a device used to examine samples in vitro (outside the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely surgical and therapeutic.
N/A
Intended Use / Indications for Use
The Endius Bipolar Sheath is intended to be used in conjunction with the Endius XPS Microdebrider System to coagulate soft tissue during various spinal surgical procedures.
The Endius Bipolar Sheath is intended to be used to coagulate soft tissue during various spinal surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
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, FX, or EZ, generator by using the Bipolar Sheath Adapter that 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): 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.
Not Found
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.
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
§ 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
Ko12488
AUG 3 0 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 SLT Bipolar Sheath
manufactured by Surgical Laser Technologies (Montgomery, PA) |
| 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, FX, or EZ,
generator by using the Bipolar Sheath Adapter that is intended to decrease the |
| 7.7 | |
| Device
Indications and
Intended use | The Endius Bipolar Sheath is intended to be used in conjunction with the
Endius XPS Microdebrider System to coagulate soft tissue during various
spinal surgical procedures. |
ಸ್ 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.
6:
()
1
7.8 Substantial Equivalence
The Endius Bipolar Sheath is substantially equivalent to the SLT Bipolar Sheath manufactured by Surgical Laser Technologies (Montgomery, PA)
| Table of Substantial Equivalence | ||
|---|---|---|
| Device Name | SLT Bipolar Sheath | Endius Bipolar Sheath and MDS Device |
| Intended use | K981041: The SLT Bipolar Sheath is intended to be used to coagulate soft tissue during ENT procedures. | |
| K984018: The SLT Bipolar Sheath is intended to be used to coagulate soft tissue during orthopedic procedures. | The Endius Bipolar Sheath is intended to be used coagulate soft tissue during various spinal surgical procedures. | |
| Materials | Stainless Steel/ polyethylene | Stainless Steel, FEP coating, plastics, adhesives |
| Sterilization/ Labeling | Single Use, sterilized by 100% Ethylene Oxide | Single use, Sterilized by gamma irradiation |
| Sizes | 3mm - 5mm | 3.5-4.5mm |
| Exposed Tip Size | 1.5 mm electrode | 3.5-4.5mm |
| Length | 8.1 cm | 6-12 cm |
| Operating Mode | To be used with ESU Generator in Bipolar Mode | To be used with ESU Generator in Bipolar Mode |
Applicant
Date 8/1/01
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is facing right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 0 2001
Ms. Susan Finneran Director Regulatory Affairs, Clinical Sciences Endius, Inc. 23 West Bacon Street Plainville, Massachusetts 02762
Re: K012488
Trade/Device Name: Endius Bipolar Sheath and Accessories Regulation Number: 878.4400 Regulatory Class: II Product Code: GEI Dated: August 2, 2001 Received: August 3, 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 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). 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 requirements, 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 I nils lotter will and w you of substantial equivalence of your device to a legally marketed nouthoution. The I Dr 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 11 you desire specific and vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 dditionally, for questions on the promotion and advertising of your device, (Jease contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monmation on Jour respons and Consumer Assistance at its toll-free number (800) 638-2041 or 1301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Susan Leacock, M.D.
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):
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)
Concurence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
(Posted July 1, 1998)
Susan Weberon
(Division Sign-Off) (Division Signi-On)
Division of General, Restorative
Division of General, Devices Division of General, and Neurological Devices
510(k) Number Ko 12 488