(109 days)
The Gyrus ACMI PKS Plasma Morcellator is intended for cutting, coring, and extracting tissue in various operative laparoscopy procedures, including laparoscopic general surgical procedures, laparoscopic urological procedures, and laparoscopic gynecologic procedures.
The Gyrus ACMI PKS Plasma Morcellator consists of two main elements: a Morcellator that includes a cutting shaft and handle with an integrated electrical cable that connects to a Gyrus Medical generator; and a Grasper that passes through the hollow shaft of the Morcellator, to grasp tissue and retract it toward the cutting element on the Morcellator shaft tip. An obturator may also be used to assist in the introduction of the device in laparoscopic procedures, and like the grasper, is positioned through the shaft of the Morcellator tube when being utilized
The provided text describes a 510(k) submission for the Gyrus ACMI PKS Plasma Morcellator, focusing on substantial equivalence to predicate devices rather than detailed performance studies with specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document.
However, I can provide what is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from predicate) | Reported Device Performance (Gyrus ACMI PKS Plasma Morcellator) |
|---|---|---|
| Tissue Cutting Technology | Bipolar electrosurgical energy to cut tissue (from Gyrus Medical Inc. PlasmaCision Laparoscopic Spatula) | Utilizes the same bipolar electrosurgical energy to cut tissue. |
| Generator Compatibility | Connects to Gyrus PlasmaKinetic SuperPulse System and Gyrus General Purpose Electrosurgical System generators (from Gyrus Medical Inc. PlasmaCision Laparoscopic Spatula) | Connects to the same electrosurgical generators. |
| Dimensional Similarity | Similar Morcellator shaft diameters (from Ethicon Gynecare Laparoscopic Morcellator) | Dimensionally similar, having similar Morcellator shaft diameters. |
| Mechanism of Action | Pistol grip Morcellator with a hollow shaft through which a grasper passes to grasp tissue to be resected (from Ethicon Gynecare Laparoscopic Morcellator) | Utilizes a pistol grip Morcellator with a hollow shaft through which a grasper is passed to grasp tissue to be resected. |
| Intended Use | Cutting, coring, and extracting tissue in various operative laparoscopy procedures, including laparoscopic general surgical, urological, and gynecologic procedures (from Ethicon Gynecare Laparoscopic Morcellator) | Indicated for cutting, coring, and extracting tissue in various operative laparoscopy procedures, including laparoscopic general surgical, urological, and gynecologic procedures. |
| Patient-Contacting Materials | Utilized in predicate devices and other legally marketed Gyrus ACMI devices | Uses patient-contacting materials that are utilized in the predicate devices, as well as other legally marketed devices manufactured by Gyrus ACMI. |
Study Proving Acceptance Criteria:
The document states: "During design verification, the performance of the PKS Plasma Morcellator was compared against the known performance characteristics of the predicate Gynecare Laparoscopic Morcellator using the bipolar tissue cutting technology of the predicate Gyrus PlasmaCision Laparoscopic Spatula. Testing demonstrated that the performance requirements were met, and that the PKS Plasma Morcellator exhibited comparable performance characteristics to both the predicate care Laparoscopic Morcellator and predicate Gyrus PlasmaCision Laparoscopic Spatula."
2. Sample size used for the test set and the data provenance:
This information is not provided in the document. The study described is a "design verification" which compared the new device against predicate devices' known characteristics, implying bench testing and comparison, not clinical trials with human subjects or specific data sets with provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The study described does not appear to involve human experts establishing ground truth in the context of diagnostic or interpretive tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document. The study described does not appear to involve adjudication of expert readings.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not provided in the document. This is a medical device (morcellator) and not an AI or diagnostic imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a medical instrument (morcellator), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" implicitly used for comparison was the "known performance characteristics" of the predicate devices. This would likely stem from previously established performance data, design specifications, and clinical experience with those predicate devices. Formal "ground truth" in the sense of pathology or outcomes data from a prospective study specifically for this device comparison is not mentioned.
8. The sample size for the training set:
This information is not provided in the document. This device does not use machine learning, so a "training set" is not relevant.
9. How the ground truth for the training set was established:
This information is not applicable as the device does not use machine learning, so there is no training set.
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MAY - 2 2008
Gyrus ACMI PKS Plasma Morcellator Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
Traditional 510(k) Notification 510(k) Summary January 11, 2008
510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. Gyrus ACMI PKS Plasma Morcellator
Page 1 of 3
General Information
Manufacturer:
Gyrus Medical Ltd. Fortran Road, St. Mellons Cardiff UNITED KINGDOM CF3 0LT
Establishment Registration Number:
510(k) Submitter:
9617070
3003790304
Terrence E. Sullivan
January 11, 2008
Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772-2104
Vice President, Regulatory Affairs
Establishment Registration Number:
Contact Person:
Date Prepared:
Device Description
Classification Name:
Laparoscope, Gynecologic and accessories (21 CFR 884.1720), Class II, Obstetrics/Gynecology Panel; Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400), Class II General and Plastic Surgery Panel
Gyrus Medical Solid Organ Resection Device (SORD)
Gyrus ACMI PKS Plasma Morcellator
Generic/Common Name:
Electrosurgical Instruments
Predicate Devices
Project Name:
Trade Name:
Gyrus Medical Inc. PlasmaCision Laparoscopic Spatula K041633 Ethicon Inc. Gynecare Laparoscopic Morcellator K993801
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Traditional 510{k) Notification 510(k) Summary January 11, 2008
Intended Uses
The Gyrus ACMI PKS Plasma Morcellator is intended for cutting, coring, and extracting tissue in various operative laparoscopy procedures, including laparoscopic general surgical procedures, laparoscopic urological procedures, and laparoscopic gynecologic procedures.
Product Description
The Gyrus ACMI PKS Plasma Morcellator consists of two main elements: a Morcellator that includes a cutting shaft and handle with an integrated electrical cable that connects to a Gyrus Medical generator; and a Grasper that passes through the hollow shaft of the Morcellator, to grasp tissue and retract it toward the cutting element on the Morcellator shaft tip. An obturator may also be used to assist in the introduction of the device in laparoscopic procedures, and like the grasper, is positioned through the shaft of the Morcellator tube when being utilized
Technological Characteristics and Substantial Equivalence
The Gyrus ACMI PKS Plasma Morcellator utilizes features incorporated into the following legally marketed predicate devices:
The Gyrus ACMI PKS Plasma Morcellator utilizes the same bipolar electrosurgical energy to cut tissue as that used in the predicate Gyrus Medical Inc. PlasmaCision Laparoscopic Spatula.
The Gyrus ACMI PKS Plasma Morcellator connects to the same electrosurgical generators, the currently marketed Gyrus PlasmaKinetic SuperPulse System and Gyrus General Purpose Electrosurgical System generators, as the predicate Gyrus Medical Inc. PlasmaCision Laparoscopic Spatula. These generators were cleared. under K031085 and K050550, respectively.
The Gyrus ACMI PKS Plasma Morcellator is dimensionally similar to the predicate Ethicon Gynecare Laparoscopic Morcellator, having similar Morcellator shaft diameters.
Like the predicate Ethicon Gynecare Laparoscopic Morcellator, the Gyrus ACMI PKS Plasma Morcellator utilizes a pistol grip Morcellator with a hollow shaft through which a grasper is passed to grasp tissue to be resected.
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Gyrus ACMI PKS Plasma Morcellator Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
Traditional 510(k) Notification 510(k) Summarv January 11, 2008
Page 3 of 3
Like the predicate Ethicon Gynecare Laparoscopic Morcellator, the Gyrus ACMI PKS Plasma Morcellator is indicated for cutting, coring, and extracting tissue in various operative laparoscopy procedures, including laparoscopic general surgical procedures, laparoscopic urological procedures, and laparoscopic gynecologic procedures.
KOQ0093
The Gyrus ACMI PKS Plasma Morcellator uses patient-contacting materials that are utilized in the predicate devices, as well as other legally marketed devices manufactured by Gyrus ACMI.
During design verification, the performance of the PKS Plasma Morcellator was compared against the known performance characteristics of the predicate Gynecare Laparoscopic Morcellator using the bipolar tissue cutting technology of the predicate Gyrus PlasmaCision Laparoscopic Spatula. Testing demonstrated that the performance requirements were met, and that the PKS Plasma Morcellator exhibited comparable performance characteristics to both the predicate care Laparoscopic Morcellator and predicate Gyrus PlasmaCision Laparoscopic Spatula.
In summary, the Gyrus ACMI PKS Plasma Morcellator is substantially equivalent to the predicate devices and presents no new questions of safety or efficacy.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2008
Gyrus ACMI, Inc. % Mr. Terrence E. Sullivan VP, Regulatory Affairs 136 Turnpike Road Southborough, Massachusetts 01772
Re: K080093
Trade/Device Name: Gyrus ACMI PKS Plasma Morcellator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, HET Dated: April 17, 2008 Received: April 18, 2008
Dear Mr. Sullivan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.
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Page 2 - Mr. Terrence E. Sullivan
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Gyrus ACMI PKS Plasma Morcellator Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
Traditional 510(k) Notification Statement of Intended Use January 11, 2008
Device Name: Gyrus ACMI PKS Plasma Morcellator
510(k) Number: K080093
Statement of Intended use:
The Gyrus ACMI PKS Plasma Morcellator is intended for cutting, coring, and extracting tissue in various operative laparoscopy procedures, including laparoscopic general surgical procedures, laparoscopic urological procedures, and laparoscopic gynecologic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: X
OR Over-the-Counter Use:
(Per 21 CFR 801.109)
Mark A. Mellman
Ayiston 2 . Restorative, ivision of Gener ad Neurological Devices
100 Number
§ 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.