(90 days)
Not Found
No
The 510(k) summary describes a standard bipolar sealing device that uses RF energy and saline. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for "haemostatic sealing and coagulation of soft tissue" and "blunt dissection" during surgical procedures, which are therapeutic actions.
No
Explanation: The device is described as a "dissecting bipolar sealer" used for "blunt dissection and for haemostatic sealing and coagulation of soft tissue". Its function is therapeutic (sealing and coagulation), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly outlines a physical, handheld "wand-like" disposable device with electrodes, a shaft, and connections for saline and electrical lines. It also mentions bench performance testing involving physical attributes and animal tissue testing, indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer is a surgical device used during a procedure to perform blunt dissection and haemostatic sealing and coagulation of soft tissue. It directly interacts with the patient's tissue in vivo (within the living body).
- Lack of Sample Analysis: The description does not mention the device analyzing any samples taken from the patient. Its function is to apply energy and saline to the tissue itself.
Therefore, the device's intended use and mechanism of action clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer is a single use, sterile. bipolar device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of radio-frequency (RF) energy and saline for blunt dissection and for haemostatic sealing and coagulation of soft tissue at the operative site. It is intended for. but not limited to, abdominal, and thoracic surgery, endoscopic, laparoscopic, and thoracoscopic procedures.
The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
Product codes
GEI
Device Description
The Aquamantys Endo DBS 8.7 device is a handheld "wand-like" disposable that, when connected to the Aquamantys Pump Generator, uses bipolar radio-frequency energy concurrent with saline for hemostatic sealing and coagulation. The device is equipped with dual electrodes at the distal tip. Saline and electrical lines enter from the opposite end (proximal end) of the device's hand piece from the distal electrodes. The device's hand piece is equipped with a blue button that activates bipolar RF energy concurrent with saline flow for blunt dissection and for hemostatic sealing and coagulation. The long, stainless steel shaft allows for the device to be used in laparoscopic, endoscopic and thoracoscopic procedures. A saline fluid delivery line is provided with the device, which includes a drip chamber/spike for insertion into saline bags. The proposed device connects to the Aquamantys Pump Generator using a three-pronged connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue at the operative site (abdominal, and thoracic surgery)
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
Bench performance testing including: visual, static cable pulls, dynamic cable pulls, static saline tube pulls, air leak and flow, hipot testing, saline flow testing, shaft deflection/pull, electrode pull, continuity, biocompatibility assessment, animal tissue testing, and electrical safety. Clinical testing was not required to establish substantial equivalence between the proposed and predicate devices.
Key Metrics
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
K123201
510(k) Summary
;
JAN 1 0 2013
| Submitter: | Medtronic Advanced Energy
180 International Drive
Portsmouth, NH 03801
USA |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tara N. Turney, RAC
Senior Regulatory Affairs Specialist
Phone: 603-742-5445
Fax: 603-742-1488
Email: tara.n.turney@medtronic.com |
| Date Prepared: | October 11th, 2012 |
| Trade Name: | Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer |
| Common Name: | Electrosurgical accessory |
| Classification
Name: | Electrosurgical Cutting and Coagulation Device and
Accessories |
| Predicate Device: | Aquamantys Double Cone Bipolar Sealer
(K101057)
Monopolar Floating Ball
(K010662) |
| Device
Description: | The Aquamantys Endo DBS 8.7 device is a handheld "wand-
like" disposable that, when connected to the Aquamantys
Pump Generator, uses bipolar radio-frequency energy
concurrent with saline for hemostatic sealing and coagulation.
The device is equipped with dual electrodes at the distal tip.
Saline and electrical lines enter from the opposite end
(proximal end) of the device's hand piece from the distal
electrodes. The device's hand piece is equipped with a blue
button that activates bipolar RF energy concurrent with saline
flow for blunt dissection and for hemostatic sealing and
coagulation. The long, stainless steel shaft allows for the
device to be used in laparoscopic, endoscopic and
thoracoscopic procedures. A saline fluid delivery line is
provided with the device, which includes a drip
chamber/spike for insertion into saline bags. The proposed
device connects to the Aquamantys Pump Generator using a
three-pronged connector. |
·
:
1
200 8 : V Statement of Intended Use:
Summary of
Technological
Characteristics:
The Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer is a single use, sterile. bipolar device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of radio-frequency (RF) energy and saline for blunt dissection and for haemostatic sealing and coagulation of soft tissue at the operative site. It is intended for. but not limited to, abdominal, and thoracic surgery, endoscopic, laparoscopic, and thoracoscopic procedures.
The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
The Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer applies the same fundamental scientific technology as the existing Medtronic Advanced Energy Aquamantys devices. The device's hand piece is equipped with a blue activation buttons that activates bipolar RF energy concurrent with saline flow for blunt dissection and for hemostatic sealing and coagulation. The device is designed to connect to the Aquamantys Pump Generator, providing connection to both RF power and the peristaltic pump for saline flow. The main differences between the proposed and predicate devices are as follows:
- . Tip Configuration
- o Clamshell tip housing with saline exit
- o Smaller electrodes
- Shaft Material
- o Stainless steel
The Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer has undergone bench performance testing to verify and validate the performance features and specifications. The testing included:
-
visual, .
. -
static cable pulls, .
-
dynamic cable pulls, .
-
static saline tube pulls, .
-
air leak and flow, .
-
. hipot testing.
-
. saline flow testing,
-
. shaft deflection/pull.
-
electrode pull. .
-
continuity .
-
biocompatibility assessment, .
Summary of Nonclinical Data:
2
- animal tissue testing, and .
- electrical safety
.
r
·
| Summary of | Clinical testing was not required to establish substantial |
|---|---|
| Clinical Data: | equivalence between the proposed and predicate devices. |
| Conclusion from | |
| Data: | Medtronic Advanced Energy has demonstrated that the |
| Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer is | |
| substantially equivalent to the predicate devices based upon | |
| indications for use, design, test results and fundamental | |
| scientific technology. |
:
:
.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Advanced Energy, LLC % Ms. Janet Kwiatkowski Regulatory Affairs Manager 180 International Drive Portsmouth, New Hampshire 03801
January 10, 2013
Re: K123201
Trade/Device Name: Aquamantys Endo DBS 8.7 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: Class II Product Code: GEI · Dated: October 11, 2012 Received: October 12, 2012
Dear Ms. Kwiatkowski:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Janet Kwiatkowski
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K123201
ﻟﻤﺴﺎﺑﻘﺎ ﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ
ﻤﺤﺴ
Aquamantys Endo DBS 8.7 Device Name:
Indications for Use:
The Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer is a single use, sterile, bipolar device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of radio-frequency (RF) energy and saline for blunt dissection and for haemostatic sealing and coagulation of soft tissue at the operative site. It is intended for, but not limited to, abdominal, and thoracic surgery, endoscopic, laparoscopic, and thoracoscopic procedures.
The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
Prescription Use X (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)
Dwight Yen 2013.01.08 14:40:12 -05'00'
(Division Sign-Off)
Division of Surgical Devices
510(k) Number ___K123201
Page 1 of _
Medtronic Advanced Energy Aquamantys Endo DBS 8.7 Traditional 510(k)
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