K Number
K093695
Device Name
PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE
Date Cleared
2010-04-13

(134 days)

Product Code
Regulation Number
878.4400
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PEAK PlasmaBlade® 3.0S Tissue Dissection Device is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.
Device Description
The PEAK PlasmaBlade® 3.0S consists of a single insulated bendable blade. telescoping shaft that can be configured in both standard and extended length and a handle with integrated controls and cable. The finger grip also incorporates a suction lumen for the evacuation of smoke and fluids. The PlasmaBlade 3.0S is an addition to the PEAK PlasmaBlade Family of Tissue Dissection devices which include the PlasmaBlade 4.0, PlasmaBlade Needle, and PlasmaBlade EXT.
More Information

Not Found

No
The summary describes a surgical cutting and coagulation device and does not mention any AI or ML components or functionalities.

Yes.
The device is used for cutting and coagulation of soft tissue during various surgical procedures, indicating a direct therapeutic action on the body.

No
The device is described as a "Tissue Dissection Device" used for "cutting and coagulation of soft tissue" during surgical procedures, indicating its function as a surgical tool rather than for diagnosis. Its intended use focuses on treatment (cutting and coagulation) of soft tissue, not on identifying or characterizing disease states.

No

The device description clearly outlines physical hardware components including a blade, shaft, handle, controls, cable, and suction lumen, indicating it is not a software-only device.

Based on the provided information, the PEAK PlasmaBlade® 3.0S Tissue Dissection Device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for "cutting and coagulation of soft tissue during General, Plastic and Reconstructive... surgical procedures." This describes a device used on the patient's body during surgery, not a device used to test samples outside the body.
  • Device Description: The description details a surgical instrument with a blade, shaft, handle, and controls. This is consistent with a surgical tool, not an IVD.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any other components typically associated with in vitro diagnostics.

IVDs are devices used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The PEAK PlasmaBlade® 3.0S is a surgical tool used for direct intervention on tissue during a procedure.

N/A

Intended Use / Indications for Use

The PEAK PlasmaBlade® 3.0S is indicated for cutting and coagulation of soft tissue during General, Plastic and reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.

Product codes (comma separated list FDA assigned to the subject device)

GEI

Device Description

The PEAK PlasmaBlade® 3.0S consists of a single insulated bendable blade. telescoping shaft that can be configured in both standard and extended length and a handle with integrated controls and cable. The finger grip also incorporates a suction lumen for the evacuation of smoke and fluids.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Soft tissue, skin

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)

Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria.

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.

PEAK PlasmaBlade® 4.0 (K082786)

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.

Not Found

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

1093695-

510(k) Summary for PEAK PlasmaBlade® 3.0S

1. Submitter Name and Address:

APR 1 8 2010

PEAK Surgical, Inc. 2464 Embarcadero Way Palo Alto, CA 94303 Phone: 650-331-3020 Fax: 650-331-3293

Contact: Lois Nakayama

January 18, 2010 Date prepared:

2. Device Name:

Trade Name:PEAK PlasmaBlade® 3.0S
Common Name:Electrosurgical Device and Accessories
Classification Name:Electrosurgical Cutting and Coagulation Device and
Accessories
Regulation Number:21 CFR § 878.4400
Product Code:GEI
Regulatory Class:Class II

3. Predicate Devices:

PEAK PlasmaBlade® 4.0 (K082786)

4. Device Description:

The PEAK PlasmaBlade® 3.0S consists of a single insulated bendable blade. telescoping shaft that can be configured in both standard and extended length and a handle with integrated controls and cable. The finger grip also incorporates a suction lumen for the evacuation of smoke and fluids.

1

The PlasmaBlade 3.0S is an addition to the PEAK PlasmaBlade Family of Tissue Dissection devices which include the PlasmaBlade 4.0, PlasmaBlade Needle, and PlasmaBlade EXT.

ડ. Intended Use:

The PEAK PlasmaBlade® 3.0S is indicated for cutting and coagulation of soft tissue during General, Plastic and reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.

Technological Characteristics 6.

The PEAK PlasmaBlade® 3.0S is similar to the predicate device in output energy, delivery system and materials. They are both electrosurgical instruments used to cut and coagulate soft tissue, utilizing RF powered distal ends. The modifications to the electrode, shaft and finger grip do not significantly affect the safety or effectiveness of the device.

7. Performance Data:

Laboratory and performance tests were executed to ensure that the device functioned as intended and met design specifications. Sufficient data were obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria.

8. Sterilization

...

The PEAK PlasmaBlade® 3.0 is provided sterile. The device is not intended for reuse or resterilization.

9. Conclusion:

By virtue of design, technology, principle of operation and intended use, the PEAK PlasmaBlade® 3.0S is substantially equivalent to the predicate device. In establishing substantial equivalence to the predicate device, PEAK Surgical evaluated the indications for use, materials incorporated, product specification and energy requirements of the device.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 25 2010

PEAK Surgical, Inc. % Ms. Lois Nakayama 2464 Embarcadero Way Palo Alto, California 94303

Re: K093695

Trade/Device Name: PEAK PlasmaBlade® 3.0S Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 26, 2010 Received: March 29, 2010

Dear Ms. Nakayama:

This letter corrects our substantially equivalent letter of April 13, 2010.

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 (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 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.

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Page 2 - Ms. Lois Nakayama

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 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,

Aluh A. Millan

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known):

K093695

Device Name: PEAK PlasmaBlade® 3.0S

Indications for Use:

The PEAK PlasmaBlade® 3.0S Tissue Dissection Device is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological surgical procedures.

.

ivision Sigh Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093695

Prescription Use X (Part 21 CFR 801 Subpart D)

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)

PEAK Surgical, Inc. Special 510(k): Device Modification-PlasmaBlade 3.0S November 27, 2009

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