(61 days)
The PK® Diego® System is intended for cutting, coagulation and removal of bone and tissue in general ENT, Head & Neck, Otoneurologic and various spinal surgical procedures.
The PK Diego System is identical to the device cleared under K034004. The system includes the same power console, footswitch, reusable handpiece and various single use, interchangeable burs and bipolar blades. The sole purpose of this submission is to expand the existing indications to include various spinal surgical procedures.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PK® Diego® System:
This 510(k) submission primarily focuses on expanding the indications for use of an already cleared device, the Diego RF Powered Dissector & Drill System (K034004), to include "various spinal surgical procedures." As such, the submission emphasizes substantial equivalence to predicate devices rather than entirely new performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (What was measured) | Reported Device Performance (How the device performed) |
|---|---|
| Bipolar cutting performance | "Testing demonstrated that the performance requirements were met, and that the PK Diego System exhibited comparable performance characteristics to both predicates." |
| Bipolar coagulation performance | "Testing demonstrated that the performance requirements were met, and that the PK Diego System exhibited comparable performance characteristics to both predicates." |
| Material biocompatibility (patient-contacting materials) | "The PK Diego System uses patient-contacting materials that are utilized in the predicate devices, as well as other legally marketed devices manufactured by Gyrus ACMI." |
| Dimensional similarity (blade shaft and tip diameters) | "The Diego bipolar blades are dimensionally similar to the predicate XPS (MDS) StraightShot Microdebrider System cleared under K973499, having similar blade shaft and tip diameters." |
| Utilization of existing technology (electrosurgical energy) | "The PK Diego System utilizes the same bipolar electrosurgical energy to cut and coagulate tissue as that used in the predicate Diego RF Dissector and Drill System..." |
| Connectivity to existing generator/console | "The PK Diego powered handpiece, burs and bipolar blades connect to the same electrosurgical generator/console, as the predicate and currently marketed Diego RF Dissector and Drill System..." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a numerical sample size for the performance testing. It generally refers to "Testing" and "comparable performance characteristics."
The data provenance is retrospective, as it compares the PK Diego System's performance and characteristics to legally marketed predicate devices that have prior clearance. There is no indication of prospective clinical or lab studies specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the involvement of experts for establishing ground truth in terms of clinical or pathological evaluation for the performance testing. The comparison is against the known performance characteristics of existing predicate devices.
4. Adjudication Method for the Test Set:
No adjudication method is mentioned as there's no indication of multiple expert assessments or a need for dispute resolution in the context of this substantial equivalence submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This 510(k) is for a surgical device, not an imaging or diagnostic aid that would typically involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This question is not applicable to the device described. The PK® Diego® System is a surgical instrument operated by a human surgeon, not an algorithm.
7. Type of Ground Truth Used:
The "ground truth" used for this submission is based on the established performance characteristics and safety profiles of the legally marketed predicate devices. This includes:
- Known tissue debridement performance (XPS (MDS) StraightShot Microdebrider System)
- Known tissue coagulation performance (Endius Bipolar Sheath)
- Existing biocompatibility of materials (predicate devices and other Gyrus ACMI devices)
- Established function of the shared power console and electrosurgical energy.
8. Sample Size for the Training Set:
The concept of a "training set" is not applicable here as the device is a mechanical/electrical surgical instrument, not an AI or machine learning model that requires training data.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the reasons stated in point 8.
{0}------------------------------------------------
PK® Diego® System Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
DEC 0 9 2008
Traditional 510(k) Notification 510(k) Summary October 8, 2008
510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. PK ®Diego® System
Page 1 of 3
General Information
Manufacturer:
Gyrus ENT, L.L.C. (subsidiary of Gyrus ACMI, Inc.) 2925 Appling Road Bartlett , TN 38113
Establishment Registration Number:
510(k) Submitter:
1037007
3003790304
October 2008
Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772-2104
Graham A. L. Baillie, MS Senior Regulatory Specialist
Establishment Registration Number:
Contact Person:
Date Prepared:
Device Description
Classification Name:
Electrosurgical Cutting & Coagulation Device and Accessories Class 2 21 CFR 878.4400 General and Plastic Surgery Panel
Project Name:
Trade Name(s):
Generic/Common Name:
Gyrus ACMI PK® Diego® System
Bipolar Coagulation Device, electrical debriders, drill handpiece, cutting blades and burs, electrical surgical shaver.
Electrosurgical cutting and coagulation device and accessories
12
{1}------------------------------------------------
PK® Diego® System Gyrus ACMI. Inc. 136 Turnpike Road Southborough, MA 01772
Traditional 510(k) Notification 5100k) Summary October 8, 2008
083013
Predicate Devices
Diego RF Powered Dissector & Drill System: Endius Bipolar Sheath: XPS (MDS) StraightShot Microdebrider System:
Page 2 of ③
Intended Uses
The PK® Diego® System is intended for cutting, coagulation and removal of bone and tissue in general ENT, Head & Neck, Otoneurologic and various spinal surgical procedures.
Product Description
The PK Diego System is identical to the device cleared under K034004. The system includes the same power console, footswitch, reusable handpiece and various single use, interchangeable burs and bipolar blades. The sole purpose of this submission is to expand the existing indications to include various spinal surgical procedures.
Technological Characteristics and Substantial Equivalence
The PK Diego System utilizes features incorporated into the following legally marketed predicate devices:
The PK Diego System utilizes the same bipolar electrosurgical energy to cut and coagulate tissue as that used in the predicate Diego RF Dissector and Drill System cleared under K034004.
The PK Diego powered handpiece, burs and bipolar blades connect to the same electrosurgical generator/console, as the predicate and currently marketed Diego RF Dissector and Drill System cleared under K034004. The Diego bipolar blades are dimensionally similar to the predicate XPS (MDS) StraightShot Microdebrider System cleared under K973499, having similar blade shaft and tip diameters.
Like the predicate XPS (MDS) StraightShot Microdebrider System (K973499) and the predicate Endius Bipolar Sheath cleared under K012488, the proposed PK Diego System includes an indication for various spinal surgical procedures.
The PK Diego System uses patient-contacting materials that are utilized in the predicate devices, as well as other legally marketed devices manufactured by Gyrus ACMI.
{2}------------------------------------------------
Continued... Technological Characteristics and Substantial Equivalence
The bipolar cutting and coagulation performance of the PK Diego System was compared against the known tissue debrider performance characteristics of the predicate XPS (MDS) StraightShot Microdebrider System and the tissue coagulation performance of the predicate Endius Bipolar Sheath. Testing demonstrated that the performance requirements were met, and that the PK Diego System exhibited comparable performance characteristics to both predicates.
In summary, the PK Diego System is substantially equivalent to the predicate devices and presents no new questions of safety or efficacy.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle-like emblem with three curved lines representing the body and wings. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 9 2008
Gyrus ACMI, Inc. % Mr. Graham A.L. Baillie Sr. Regulatory Specialist 136 Turnpike Road Southborough, Massachusetts 01772
Re: K083013
Trade/Device Name: Gyrus ENT PK® Diego® Powered Dissector Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 8, 2008 Received: October 9, 2008
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 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
{4}------------------------------------------------
Page 2 - Mr. Graham A.L. Baillie
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.
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 Presmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse vents (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems a 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. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Gyrus ACMI PK® Diego@ System Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772
Traditional 510(k) Notification Statement of Intended Use September 11, 2008
Indications for Use
510(k) Number: 083013
Device Name: Gyrus ENT PK® Diego® Powered Dissector
Indications for Use:
The Diego PK System is intended for cutting, coagulation and removal of bone and tissue in general ENT, Head & Neck, Otoneurologic and various spinal surgical procedures.
Prescription Use: ਮ (Per 21 CFR 801.109)
AND/OR
Over-the-Counter Use: (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nudlho Oydin formxm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K083013
§ 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.