(52 days)
No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or specific algorithms. The description focuses on the device's mechanical and electrical functions for cutting, sealing, and coagulation.
Yes
The device is used for cutting, vessel ligation, coagulation, grasping, and dissection during surgical procedures, which are all therapeutic actions.
No
Explanation: The device is indicated for surgical procedures involving cutting, ligating, coagulating, grasping, and dissecting tissues and vessels. It is a surgical instrument and not designed for diagnostic purposes.
No
The device description explicitly states it is comprised of a mixture of plastics, metals, heatshrink, and epoxy, indicating it is a physical hardware device. It also describes a handle, buttons, and a toggle switch.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for cutting, sealing, coagulation, grasping, and dissection of tissues and vessels within the body during open, general surgery. This is a therapeutic and surgical function, not a diagnostic one performed on samples outside the body.
- Device Description: The description details a surgical instrument with a handle, buttons, and a toggle switch, designed to be used with a generator. This aligns with a surgical tool, not a device for analyzing biological samples.
- Performance Studies: The performance studies described are bench and animal studies evaluating the device's ability to seal lymphatics and its tissue effects in vivo or ex vivo tissue samples, not diagnostic accuracy or performance on patient samples for diagnostic purposes.
IVD devices are used to examine specimens (like blood, urine, or tissue samples) taken from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is directly on the patient's tissues and vessels during surgery.
N/A
Intended Use / Indications for Use
The PK AIM is indicated for open, general surgery (including plastic and re-constructive) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping and dissection is performed. The device has been designed to seal and cut vessels (up to and including 3 mm in diameter), tissue bundles, and lymphatics when used with the Olympus ESG-400 Generator.
This device is not intended to be used for tubal ligation or female sterilization.
Product codes
GEI
Device Description
Both predicate PK AIM and proposed PK AIM devices can be described as 2 in 1 devices with a pencil type handle that combines the technologies of a monopolar pencil and a bipolar forceps. The device has buttons that allow hand activation and a sliding toggle switch to allow the surgeon to switch between a forceps, and a pencil device. Foot pedals connected to the generator are also available to allow for foot pedal activation of the device. Both predicates (Olympus OFJ and Olympus PK AIM connect/plug into the Olympus ESG-400 generator (K141225). The generator and subject device make up a medical electrical system. The PK AIM instrument is to be used only with the Olympus ESG-400 Generator.
The proposed device is comprised of a mixture of plastics, metals heatshrink and epoxy. The predicate Olympus PK AIM passed all applicable biocompatibility testing and additional information was provided within in K152219 for any patient contacting materials that contain colorants. The subject Olympus PK AIM and predicate Olympus PK AIM are physically identical - no design or material changes whatsoever have been made to patient contacting surfaces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The predicate PK AIM (K163373) and proposed PK AIM are identical in every respect. No physical design changes were made to the handle or distal grasping forceps and monopolar components that would require the repeat of performance testing already provided in the original PK AIM, K152219. Performance of the proposed PK AIM is substantially equivalent to the predicate PK AIM.
Bench (tissue testing) and animal (lymphatic sealing) studies described below were conducted by American Preclinical Services (APS) in support of the desired additional indications.
Lymphatic Sealing: An acute GLP study was conducted to assess the lymphatic sealing performance of the proposed PK Advanced Integrated Multifunctional Device as compared to the predicate THUNDERBEAT Open Fine Jaw in a healthy porcine model. The study was conducted by APS located in Minneapolis, MN. The control article (predicate) was the THUNDERBEAT Open Fine Jaw (TB OFJ). The OFJ is an Ultrasonic and bipolar energy seal and cut device (K151743) for cut and coagulation of tissue. One animal underwent multiple lymphatic vessel seals. 15 mesenteric lymph vessels were sealed with the test device and 16 mesenteric lymph vessels were sealed with the control device. The study surgeon evaluated each seal immediately post seal and then again 30 seconds to one minute post seal.
The surgeon evaluated each vessel seal for integrity, tissue sticking, and char. All vessels sealed with the proposed PK AIM test article had no tissue sticking and no charring. All vessel seals had no leakage of lymph and had complete hemostasis immediately and at 30 seconds to one minute post seal. All vessel seals sealed with the OFJ control article had no tissue sticking and no charring. All vessel seals had no leakage of lymph and had complete hemostasis immediately and at 30 seconds to one minute post seal. All study endpoints were met. The proposed PK AIM test article performed equivalent to the predicate OFJ control article as evaluated by the study surgeon per section 3.3.1 of the study protocol. All sealed lymph vessels were sealed immediately with no lymph leakage and remained sealed at the 30 seconds to one minute time point.
Bench/ex-vivo tissue study
APS conducted a GLP ex-vivo study to evaluate tissue effect performance of the Olympus PK AIM device and the predicate Olympus OFJ. The purpose of the study was to compare tissue changes between the PK AIM device and the OFJ in ex-vivo swine liver, swine kidney and bovine cardiac muscle tissue.
Bench Ex Vivo Design Verification testing demonstrated that the requirements defined in the protocol were met. This bench ex vivo tissue test data confirms that the proposed PK AIM tissue performance is substantially equivalent to the predicate Olympus Thunderbeat OFJ.
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002
May 19, 2017
Gyrus ACMI Inc. % Mr. Graham Baillie Regulatory Affairs Manager 136 Turnpike Road Southborough, Massachusetts 01772
Re: K170908
Trade/Device Name: PK AIM Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 27, 2017 Received: March 28, 2017
Dear Mr. Baillie:
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 Actinclude 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
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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, Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S.
Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170908
Device Name PK AIM
Indications for Use (Describe)
The PK AIM is indicated for open, general surgery (including plastic and re-constructive) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping and dissection is performed. The device has been designed to seal and cut vessels (up to and including 3 mm in diameter), tissue bundles, and lymphatics when used with the Olympus ESG-400 Generator.
This device is not intended to be used for tubal ligation or female sterilization.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Olympus - PK AIM Gyrus ACMI, Inc.
Traditional 510(k) Notification March 27, 2017
P 1/7
510(k) Summary Gyrus ACMI, Inc.
Olympus PK AIM
General Information
Manufacturer:
Gyrus ACMI, Inc. 9600 Louisiana Ave North Brooklyn Park, MN 55445 Phone: 508-804-2690
3011050570
3003790304
March 27, 2017
Gyrus ACMI, Inc. 136 Turnpike Rd.
Establishment Registration Number: 510(k) Submitter:
Establishment Registration Number:
Contact Person:
Graham A. L. Baillie MS Regulatory Affairs Manager 508-804-2738 Graham.baillie@olympus-osta.com
Southborough, MA 01772-2104
Date Prepared:
Device Description
Classification Name:
- Regulation number Product code Regulatory class Review Panel Trade Name: Generic/Common Name:
Predicate Devices
Electrosurgical cutting and coagulation device and accessories 21 CFR 878.4400 GEI Class II General and Plastic Surgery Olympus PK AIM
Electrosurgical cutting and coagulation device
Olympus PK AIM Olympus Open Fine Jaw (OFJ)
Comparison to Predicate Devices:
The Olympus PK AIM (Plasma Kinetic Advanced Integrated Multifunctional Device) has been compared to predicate Olympus PK AIM and Olympus Thunderbeat Open Fine Jaw (TB OFJ) with respect to intended use, design, and fundamental scientific technology. The comparisons and testing results presented in this 510(k) notification
4
4
to FDA show this device to be substantially equivalent to predicate devices and raises no new concerns or safety or effectiveness.
Like the predicate PK AIM, the proposed PK AIM is also intended for monopolar cutting and coagulation, grasping, bipolar coagulation of selected soft tissues, and to seal vessels up to 3.0 mm in diameter during electro surgery. The proposed PK AIM will also carry additional indications currently cleared by K151743 - the Olympus Open Fine Jaw (OFJ). The sole purpose of this submission is to expand the PK AIM intended use to include " ... open, general surgery (including plastic and reconstructive) "tissue bundles, and lymphatics." Both predicate OFJ and proposed PK AIM devices are not intended to be used for tubal ligation or female sterilization.
Product Description
Both predicate PK AIM and proposed PK AIM devices can be described as 2 in 1 devices with a pencil type handle that combines the technologies of a monopolar pencil and a bipolar forceps. The device has buttons that allow hand activation and a sliding toggle switch to allow the surgeon to switch between a forceps, and a pencil device. Foot pedals connected to the generator are also available to allow for foot pedal activation of the device. Both predicates (Olympus OFJ and Olympus PK AIM connect/plug into the Olympus ESG-400 generator (K141225). The generator and subject device make up a medical electrical system. The PK AIM instrument is to be used only with the Olympus ESG-400 Generator.
The proposed device is comprised of a mixture of plastics, metals heatshrink and epoxy. The predicate Olympus PK AIM passed all applicable biocompatibility testing and additional information was provided within in K152219 for any patient contacting materials that contain colorants. The subject Olympus PK AIM and predicate Olympus PK AIM are physically identical - no design or material changes whatsoever have been made to patient contacting surfaces..
Technological Characteristics
The proposed Olympus PK AIM uses monopolar energy in order to cut and bipolar energy in order to coagulate soft tissue in general surgical procedures. For safety and convenience the ESG-400 generator recognizes the proposed Olympus PK AIM when it is connected and limits generator settings to those dedicated for use with the proposed Olympus PK AIM device. These settings are called out in the IFU.
The Olympus PK AIM can be activated using buttons located on the device handle, or via a foot pedals which are sold separately. The hand activation allows the physician to activate either cut or coagulation (coag) mode without taking their eyes off the surgical site. A sliding toggle switch located on the handle allows the user to switch between using the device as a pencil or forceps.
Material
No material changes were made to the predicate PK AIM model PK-A12055 cleared most recently under K163373.
5
Olympus - PK AIM Gyrus ACMI, Inc.
Traditional 510(k) Notification March 27, 2017
Indications for Use
P 3/7
The PK AIM is indicated for open, general surgery (including plastic and re-constructive) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping and dissection is performed. The device has been designed to seal and cut vessels (up to and including 3 mm in diameter), tissue bundles, and lymphatics when used with the Olympus ESG-400 Generator.
This device is not intended to be used for tubal ligation or female sterilization.
Compliance to Voluntary Standards
The design of the proposed PK AIM device continues to comply with the following standards:
ISO 10993-1, 2009 ISO 10993-5, 2009 ISO 10993-7 2008 ISO 10993-10, 2010 ANSI/AAMI/ISO 11607-1, 2006 ANSI/AAMI/ISO 11135-1, 2007 ISO 14971, 2007 ISO 15223-1: 2012 IEC 60601-1: 2005 IEC 60601-2-2: 2009
Summary of Sterilization and Shelf Life Discussion
Like the predicate Olympus PK AIM (K163373), the proposed Olympus PK AIM will be distributed in a sterile state and is intended for single patient use only. The sterilization method used is ethylene oxide and has a shelf life of 3 years. Sterilization method and shelf life remain identical to the predicate PK AIM.
Summary of Performance Testing
The predicate PK AIM (K163373) and proposed PK AIM are identical in every respect. No physical design changes were made to the handle or distal grasping forceps and monopolar components that would require the repeat of performance testing already provided in the original PK AIM, K152219. Performance of the proposed PK AIM is substantially equivalent to the predicate PK AIM.
Bench (tissue testing) and animal (lymphatic sealing) studies described below were conducted by American Preclinical Services (APS) in support of the desired additional indications.
Lymphatic Sealing: An acute GLP study was conducted to assess the lymphatic sealing performance of the proposed PK Advanced Integrated Multifunctional Device as compared to the predicate THUNDERBEAT Open Fine Jaw in a healthy porcine model. The study was conducted by APS located in Minneapolis, MN. The control article (predicate) was the THUNDERBEAT Open Fine Jaw (TB OFJ). The OFJ is an Ultrasonic and bipolar energy seal and cut device (K151743) for cut and coagulation of tissue. One animal underwent multiple lymphatic vessel seals. 15 mesenteric lymph vessels were sealed with the test device and 16 mesenteric lymph vessels were sealed
6
with the control device. The study surgeon evaluated each seal immediately post seal and then again 30 seconds to one minute post seal.
The surgeon evaluated each vessel seal for integrity, tissue sticking, and char. All vessels sealed with the proposed PK AIM test article had no tissue sticking and no charring. All vessel seals had no leakage of lymph and had complete hemostasis immediately and at 30 seconds to one minute post seal. All vessels sealed with the OFJ control article had no tissue sticking and no charring. All vessel seals had no leakage of lymph and had complete hemostasis immediately and at 30 seconds to one minute post seal. All study endpoints were met. The proposed PK AIM test article performed equivalent to the predicate OFJ control article as evaluated by the study surgeon per section 3.3.1 of the study protocol. All sealed lymph vessels were sealed immediately with no lymph leakage and remained sealed at the 30 seconds to one minute time point.
Bench/ex-vivo tissue study
APS conducted a GLP ex-vivo study to evaluate tissue effect performance of the Olympus PK AIM device and the predicate Olympus OFJ. The purpose of the study was to compare tissue changes between the PK AIM device and the OFJ in ex-vivo swine liver, swine kidney and bovine cardiac muscle tissue.
Bench Ex Vivo Design Verification testing demonstrated that the requirements defined in the protocol were met. This bench ex vivo tissue test data confirms that the proposed PK AIM tissue performance is substantially equivalent to the predicate Olympus Thunderbeat OFJ.
Substantial Equivalence
The proposed Olympus PK AIM has the identical design, materials, packaging and scientific technology as its predicate Olympus PK AIM device. The predicate PK AIM and proposed PK AIM device are both a pencil and a forceps device with a dual cord that provides mono and bipolar energy from the same Olympus ESG-400 Generator.
The predicate and proposed PK AIM devices are physically identical and will only differ with the addition of indications carried by the predicate Olympus OFJ. The OFJ was included as a predicate because of its similar Bipolar/RF technology generated by the same Olympus ESG-400 Generator and because it carries the additional indications desired for the proposed PK AIM that include: "open, general surgery (including plastic and re-constructive) tissue bundles and lymphatics."
| Design
Feature | Proposed
Olympus PK AIM | Predicate
Olympus PK AIM
K163373 | Predicate
Thunderbeat OFJ
K151743 | Comments |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Function of
Device | Forceps/Pencil | Forceps/Pencil | Hemostat style body | Identical to
Predicate PK
AIM |
| Tip Size | Forceps:1mm tip | Forceps:1mm tip | 2mm tip, 3mm base | Identical to |
| Design | Proposed | Predicate | Predicate | Comments |
| Feature | Olympus PK AIM | Olympus PK AIM
K163373 | Thunderbeat OFJ
K151743 | |
| | 2mm base
Pencil: 2mm | 2mm base
Pencil: 2mm | 2mm base
Pencil: 2mm | Predicate PK
AIM, similar
to OFJ |
| Energy | Monopolar/Bipolar | Monopolar/Bipolar | Bipolar/ultrasonic | In Seal mode
the OFJ uses
only bipolar
energy from
the ESG-400
to enable
vessel, tissue
bundle and
lymphatic |
| Activation | Hand / Footpedal | Hand / Footpedal | Hand / Footpedal | sealing and
hemostasis
Same |
| Plug | Dual (mono/bi) | Dual (mono/bi) | Bipolar/ultrasonic | Identical to
Predicate PK
AIM. Same
RF source. |
| Electrode
Materials | Stainless Steel | Stainless Steel | Grasping section:
PTFE/Aluminum
Probe: Ti6AI-4V | PK AIM
matls are
identical OFJ
are similar |
| Sterility | SAL 10-6
EtO | SAL 10-6
EtO | SAL 10-6
EtO | Identical |
| Single Use | Yes | Yes | Yes | Identical |
| Intended Use | The PK AIM is
indicated for open,
general surgery
(including plastic and
re-constructive) or in
any procedure in
which cutting, vessel
ligation (sealing and
cutting), coagulation,
grasping and
dissection is
performed. The device
has been designed to
seal and cut vessels
(up to and including 3
mm in diameter),
tissue bundles, and
lymphatics.
This device is not
intended to be used for
tubal ligation or
female sterilization. | The PK AIM is
intended for mono
polar cutting &
coagulation,
grasping, bipolar
coagulation of
selected soft tissues
and sealing vessels
up to and including
3.0 mm in diameter
during electro
surgery.
This device is not
intended to be used
for tubal ligation or
female
sterilization. | THUNDERBEAT
Open Fine Jaw hand
instrument is
intended to be used
with the Ultrasonic
Generator (USG-
400), the
Electrosurgical
Generator (ESG-
400), and the
THUNDERBEAT
Transducer, (TD-
TB400).
Seal & Cut mode:
The
THUNDERBEAT
Open Fine Jaw hand
instrument when
used in combination
with the Seal & Cut
mode is indicated
for open, general
surgery (including
plastic and
reconstructive, etc.) | Predicate and
proposed PK
AIM devices
are the same
except for the
addition of
indications
carried by the
predicate
OFJ. The
OFJ was
included as a
predicate
because of its
similar
technology
and it carries
additional
indications
that include:
open, general
surgery
(including
plastic and re-
constructive) |
| March 27, 2017
P 6/7 | | | | |
| Design
Feature | Proposed
Olympus PK AIM | Predicate
Olympus PK AIM
K163373 | Predicate
Thunderbeat OFJ
K151743 | Comments |
| | | | in which cutting,
vessel ligation
(sealing and
cutting),
coagulation,
grasping, and
dissection is
performed. The
device has been
designed to seal and
cut vessels (up to
and including 7 mm
in diameter), tissue
bundles, and
lymphatics.
This mode is also
indicated for open
ENT procedure in
adults
(thyroidectomy,
parathyroidectomy,
parotidectomy, and
tonsillectomy) for
only ligation
(sealing and cutting)
of vessels,
lymphatics and
tissue bundles 2-
3mm*1 away from
unintended
thermally sensitive
structures such as
nerves and
parathyroid glands.
Seal mode:
The
THUNDERBEAT
Open Fine Jaw hand
instrument when
used in combination
with the Seal mode
is indicated for
open, general
surgery (including
plastic and
reconstructive, etc.)
or in any procedure
in which vessel
sealing, coagulation,
grasping is
performed The | and
lymphatics . |
| Design | Proposed | Predicate | Predicate | Comments |
| Feature | Olympus PK AIM | Olympus PK AIM
K163373 | Thunderbeat OFJ
K151743 | |
| | | | device has been
designed to seal
vessels (up to and
including 7 mm in
diameter), tissue
bundles, and
lymphatics.
This mode is also
indicated for open
ENT procedure in
adults
(thyroidectomy,
parathyroidectomy,
parotidectomy, and
tonsillectomy) for
sealing of vessels,
lymphatics and
tissue bundles 2-
3mm*1 away from
unintended
thermally sensitive
structures such as
nerves and
parathyroid glands.
The
THUNDERBEAT
Open Fine Jaw hand
instrument has not
been shown to be
effective for tubal
sterilization or tubal
coagulation for
sterilization
procedures, and
should not be used
for these procedures.
*1 It should be
extended
appropriately
depending on the
operation situation. | |
Please refer to the following Substantial Equivalence Comparison Table:
7
8
9
Conclusion:
In summary, bench testing confirmed that the proposed Olympus PK AIM is substantially equivalent to the predicate Olympus PK AIM and Olympus OFJ devices and presents no new questions of safety or efficacy.