(38 days)
No
The description focuses on the electrosurgical mechanism and mechanical controls, with no mention of AI or ML for analysis, decision-making, or control.
Yes
The device is described as a bipolar electrosurgical device intended for procedures where ligation of vessels, tissue bundles, and lymphatics is desired, and it seals and divides tissues, which falls under therapeutic intervention.
No
The device is described as a bipolar electrosurgical device intended for use in surgical procedures to ligate and divide vessels, tissue bundles, and lymphatics. Its function is to seal and cut tissue using high-frequency energy, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical, hand-held electrosurgical instrument with mechanical components (pistol grip handle, jaws, cutting blade) and intended for use with an electrosurgical generator. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The POWERSEAL Sealer and Divider is a surgical instrument used during surgical procedures to seal and cut tissue and vessels within the body. It directly interacts with the patient's internal anatomy.
- Intended Use: The intended use clearly states its purpose in "laparoscopic/minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired." This is a surgical function, not a diagnostic one performed on specimens outside the body.
- Device Description: The description details a hand-held electrosurgical instrument with jaws and a cutting blade, designed for use with an electrosurgical generator to apply energy to tissue in vivo.
The device's function and intended use are entirely focused on surgical intervention within the body, not on analyzing specimens taken from the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The POWERSEAL devices can be used on vessels (arteries and veins, pulmonary arteries, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to. Nissen fundoplication, colectomy, adhesiolysis, sleeve gastrectomy, hysterectomy, oophorectomy.
The POWERSEAL Sealer and Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the POWERSEAL devices for these procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The POWERSEAL 5mm laparoscopic curved jaw sealer divider is an electrosurgical bipolar device with an integral extending cutting blade. It features a pistol grip handle and will be provided in shaft lengths of 23, 37, and 44 cm.
The subject POWERSEAL devices will be provided as sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with Olympus electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics.
The jaws of the POWERSEAL are designed to seal vessels, and grasp and dissect tissue during open and minimally invasive general surgical procedures using high frequency (HF) energy. A hand actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing is complete, the user operates a third control to activate a blade, which divides the tissue along the seal line.
The subject device. POWERSEAL Sealer and Divider is a class II medical devices under the regulation number 878.4400 and the product code GEI - "Electrosurgical cutting and coagulation device and accessories". Regulation Medical Specialty: General & Plastic Surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels (arteries and veins, pulmonary arteries, pulmonary veins), lymphatics, and tissue bundles.
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)
Non-clinical testing was conducted as part of demonstrating substantial equivalence to the predicate device and ensure that the performance criteria was met when used with the additional compatible generator. A risk analysis was completed to identify any new risks associated with the modification to the POWERSEAL Curved Jaw Sealer and Divider, Double Action. The following tests associated with the device modification were performed on the subject device according to the methods and acceptance criteria established in the original clearance K203682:
- . Non-clinical (electrical, mechanical, functional)
- . Preclinical (simulated use) evaluation and testing of tissue effects and thermal safety and vessel burst pressure testing and vessel thermal margin
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.
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
September 27. 2021
Olympus Surgical Technologies America Christina Flores Manager, Regulatory Affairs 9600 Louisiana Blvd North Brooklyn Park, Minnesota 55455
Re: K212643
Trade/Device Name: POWERSEAL Curved Jaw Sealer and Divider, Double Action Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: August 18, 2021 Received: August 20, 2021
Dear Christina Flores:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
POWERSEAL Curved Jaw Sealer and Divider, Double Action (PS-0523CJDA, PS-0537CJDA, PS-0544CJDA)
Indications for Use (Describe)
The POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. POWERSEAL devices can be used on vessels (arteries and veins, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, adhesiolysis, sleeve gastrectomy, hysterectomy, oophorectomy.
The POWERSEAL Sealer and Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the POWERSEAL devices for these procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. POWERSEAL Curved Jaw Sealer and Divider, Double Action
Date Prepared:
August 16, 2021
General Information
Manufacturer:
Gyrus ACMI, Inc. 9600 Louisiana Blvd. North Brooklyn Park, MN 55455 USA
Establishment Registration Number:
Contact Person:
3011050570
Christina Flores Manager, Regulatory Affairs
Device Description
| Proprietary names: | POWERSEAL Curved Jaw Sealer and
Divider, Double Action (PS-0523CJDA,
PS-0537CJDA, PS-0544CJDA) |
|-------------------------------|------------------------------------------------------------------------------------------------------|
| Device Classification Name: | Electrosurgical Cutting and Coagulation
device and Accessories |
| Regulations number: | 21 CFR 878.4400 |
| Regulation Medical Specialty: | General and Plastic Surgery |
| Regulatory Class: | Class II |
| Product Code: | GEI |
| Generic/Common Name: | Electrosurgical Cutting and Coagulation
device and Accessories |
Predicate Devices
The POWERSEAL Curved Jaw Sealer and Divider, Double Action (PS-0523CJDA, PS-0537CJDA, and PS-0544CJDA) were cleared under K203682. This submission is
4
a modification to the device that intends to add compatibility with an Olympus generator, ESG-410 cleared under K203277.
The predicate device has not been subject to any recalls.
Product Description
The POWERSEAL 5mm laparoscopic curved jaw sealer divider is an electrosurgical bipolar device with an integral extending cutting blade. It features a pistol grip handle and will be provided in shaft lengths of 23, 37, and 44 cm.
The subject POWERSEAL devices will be provided as sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with Olympus electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles, and lymphatics.
The jaws of the POWERSEAL are designed to seal vessels, and grasp and dissect tissue during open and minimally invasive general surgical procedures using high frequency (HF) energy. A hand actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing is complete, the user operates a third control to activate a blade, which divides the tissue along the seal line.
The subject device. POWERSEAL Sealer and Divider is a class II medical devices under the regulation number 878.4400 and the product code GEI - "Electrosurgical cutting and coagulation device and accessories". Regulation Medical Specialty: General & Plastic Surgery.
The device is compliant with FDA recognized consensus safety standards as listed in Appendix 13B.
Technological Characteristics
The POWERSEAL Curved Jaw Sealer and Divider, Double Action (PS-0523CJDA, PS-0537CJDA, and PS-0544CJDA) is unchanged from the predicate device as cleared under K203682 in terms of intended use, design, performance, and technological characteristics. The only difference is in the labeling that identifies an additional compatible Olympus generator.
Material
The materials have not changed for these devices since their original clearance under K203682, in which full biocompatibility information was provided.
5
Indications for Use
The intended use of the modified device, as described in its labeling, has not changed as a result of the modification. The indications for use are as follows:
The POWERSEAL Sealer and Divider is a bipolar electrosurgical device intended for use in laparoscopic/minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The POWERSEAL devices can be used on vessels (arteries and veins, pulmonary arteries, pulmonary veins) up to and including 7 mm, lymphatics, and tissue bundles. POWERSEAL devices are indicated for use in general surgery and such surgical specialties as urologic, colorectal, bariatric, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to. Nissen fundoplication, colectomy, adhesiolysis, sleeve gastrectomy, hysterectomy, oophorectomy.
The POWERSEAL Sealer and Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the POWERSEAL devices for these procedures.
Compliance to Voluntary Standards
| Standards
Number | Standard Title | FDA
Recognition
no + date | Testing Lab |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-------------------------------|
| AAMI/ANSI ES
60601-
1:2005/(R)2012
and
C1:2009/(R)2012
and,
A2:2010/(R)2012 | Medical electrical equipment - Part 1:
General requirements for basic safety
and essential performance (IEC 60601-
1:2005, MOD) | 19-4
07/09/2014 | Intertek, Fridely, MN,
USA |
| IEC 60601-1-2
Ed. 4.0:2014-02 | Medical electrical equipment - Part 1-2:
General requirements for basic safety
and essential performance - Collateral
Standard: Electromagnetic disturbances
-Requirements and tests | 19-8
09/17/2018 | Intertek, Fridely, MN,
USA |
| IEC 60601-2-2
Ed. 6.0:2017-03 | Medical electrical equipment - Part 2-2:
Particular requirements for the basic
safety and essential performance of high
frequency surgical equipment and high
frequency surgical accessories | 6-389
08/21/2017 | Intertek, Fridely, MN,
USA |
| IEC 62366-1 Ed.
1.0:2015-02 | Medical devices - Part 1: Application of
usability engineering to medical devices
[Including CORRIGENDUM 1 (2016)] | 5-114
12/23/2016 | N/A |
| ISO 14971 | Medical devices – Application of risk | 5-40 | N/A |
The design of the POWERSEAL Curved Jaw Sealer and Divider, Double Action complies with the following standards:
6
| Second Edition
| 2007-03-01 | management to medical devices | 06/27/2016 | |
|---|---|---|---|
| ISO 11135: 2014 | Sterilization of health care products - | ||
| Ethylene oxide - Requirements for | |||
| development, validation and routine | |||
| control of a sterilization process for | |||
| medical devices | 14-529 | ||
| 07/15/2019 | N/A | ||
| ISO 11607-1 | |||
| Second Edition | |||
| 2019-2 | Packaging for terminally sterilized | ||
| medical devices - Part 1: Requirements | |||
| for materials, sterile barrier systems and | |||
| packaging systems | 14-530 | ||
| 07/15/2019 | N/A | ||
| ASTM F1980-16 | Standard Guide for Accelerated Aging | ||
| of Sterile Barrier Systems for Medical | |||
| Devices | 14-497 | ||
| 12/23/2016 | N/A | ||
| ISO 10993- | |||
| 5:2009 | Biological Evaluation of Medical | ||
| Devices, Part 5: Tests for In Vitro | |||
| Cytotoxicity | 2-245 | ||
| 12/23/2016 | WuXi AppTec in St. Paul, | ||
| MN | |||
| ISO 10993- | |||
| 10:2010 | Biological Evaluation of Medical | ||
| Devices, Part 10: Tests for Irritation and | |||
| Skin Sensitization | 2-174 | ||
| 07/26/2016 | WuXi AppTec in St. Paul, | ||
| MN | |||
| ISO 10993-11 | |||
| Third Edition | |||
| 2019-09 | Biological Evaluation of Medical | ||
| Devices, Part 11: Tests for Systemic | |||
| Toxicity | 2-255 | ||
| 09/17/2018 | WuXi AppTec in St. Paul, | ||
| MN | |||
| ISO 10993-7 | |||
| Second Edition | |||
| 2008-10-15 | Biological evaluation of medical devices |
- Part 7: Ethylene oxide sterilization
residuals | 14-408
01/30/2014 | WuXi AppTec in St. Paul,
MN |
| ISO 10993-
18:2020 | Biological evaluation of medical devices
— Part 18: Chemical characterization of
medical device materials within a risk
management process | 2-276
07/06/2020 | WuXi AppTec in St. Paul,
MN |
Summary of Sterilization and Shelf Life Discussion
The product and packaging materials as well as the sterilization mode has not changed since the original clearance in K203682, therefore no additional testing was needed.
Summary of Performance Testing
Non-clinical testing was conducted as part of demonstrating substantial equivalence to the predicate device and ensure that the performance criteria was met when used with the additional compatible generator. A risk analysis was completed to identify any new risks associated with the modification to the POWERSEAL Curved Jaw Sealer and Divider, Double Action. The following tests associated with the device modification were performed on the subject device according to the methods and acceptance criteria established in the original clearance K203682:
- . Non-clinical (electrical, mechanical, functional)
7
- . Preclinical (simulated use) evaluation and testing of tissue effects and thermal safety and vessel burst pressure testing and vessel thermal margin
Substantial Equivalence Discussion
The POWERSEAL Curved Jaw Sealer and Divider, Double Action has identical indications for use as the previously cleared POWERSEAL Curved Jaw Sealer and Divider, Double Action. There have been no changes in the device compared to the previously cleared device in K203682. The only difference is the compatibility with an additional cleared Olympus generator, ESG-410. The labeling has been updated to reflect this additional compatible generator.
Conclusion
In summary, the Gyrus ACMI POWERSEAL Curved Jaw Sealer and Divider, Double Action is substantially equivalent to the predicate devices and presents no new questions of safety or effectiveness.