CSS

K031564 · Medical Scientific, Inc. · GEI · Oct 7, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031564
• Device Name: CSS
• Applicant: Medical Scientific, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 7, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CSS is intended to be used in conjunction with the powered debrider cutter systems to cut and coagulate soft tissue during arthroscopic surgical procedures.

Device Story

The CSS is an accessory sheath designed to fit over straight automated arthroscopic debrider blades. It functions as a bipolar electrosurgical device to provide spot coagulation or continuous coagulation of soft tissue while the debrider blade is in operation. Used in arthroscopic surgical procedures by surgeons, the device connects to an electrosurgical unit (ESU) and the debrider system. By enabling simultaneous cutting and coagulation, it assists in maintaining hemostasis during tissue resection, potentially reducing procedure time and improving surgical field visibility.

Clinical Evidence

Bench testing only. Testing was conducted to determine device functionality and conformance to design input requirements.

Technological Characteristics

Bipolar electrosurgical accessory sheath; fits over straight automated debrider blades; available in various diameters and lengths; energy source: external electrosurgical unit (ESU).

Indications for Use

Indicated for use in conjunction with powered debrider cutter systems to cut and coagulate soft tissue during arthroscopic surgical procedures.

Regulatory Classification

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.

Predicate Devices

• MSI Bipolar Sheath (K011202)
• Stryker Serfac (K991960)

Submission Summary (Full Text)

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K031564

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Medical Scientific, Inc. 125 John Hancock Rd. Taunton, Ma. 02780 Tel: [phone] Fax: [phone]

## 510K Summary of Safety and Effectiveness May 12, 2003 Case A Modification to the MSI Bipolar Sheath

#### 1 . Sponsor Name

OCT = 7 2003

Medical Scientific, Inc. 125 John Hancock Rd. Taunton, Ma. 02780

#### 2. Device Name

Proprietary Name: CSS Common Name: Coagulation Device Classification Name: Electrosurgical cutting and coagulation device and accessories

- Identification of Legally Marketed Device 3. MSI Bipolar Sheath, K011202 Stryker Serfac K991960
### 4. Device Description

The CSS is an accessory device that is intended to be used in conjunction with currently marketed automated debrider systems and ESU's the same as the current MSI Bipolar Sheath. The CSS is designed to fit directly over various sizes of straight automated debrider system blades. The CSS will be available in a variety of diameters and in lengths. When the CSS is inserted over one of the debrider blades, the device may be used to cauterize tissue. The CSS can be utilized to provide spot coagulation or to coagulate tissue while the debrider blade is in operation.

- 5. Intended Use
The CSS is intended to be used in conjunction with the powered debrider cutter systems to cut and coagulate soft tissue during various arthroscopic surgical procedures.

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K031564 2 of 2

- 6. Comparison of Technological Characteristics
The CSS is substantially equivalent in design, materials, construction and intended use as those of the predicates identified above. Since the CSS is the same in intended use and technological characteristics as the predicate devices, the CSS does not raise any new safety and efficacy concerns when compared to these similar legally marketed devices. The differences in power have been substantiated through applicable performance testing.

- 7. Performance Testing
Bench testing was conducted to determine device functionality and conformance to design input requirements.

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Public Health Service

OCT - 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Paul Nardella President Medical Scientific, Inc. 125 John Hancock Road Taunton, Massachusetts 02780

Re: K031564 Trade/Device Name: CSS Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 8, 2003 Received: September 12, 2003

Dear Mr. Nardella:

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. Paul Nardella

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

b Mark N. Milken

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

ଦିଆଯାଇଥିଲେ । ଏହା ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପାଇଁ ପ Device Name:

Indications For Use:

The CSS is intended to be used in conjunction with the powered debrider cutter systems to cut and coagulate soft tissue during arthroscopic surgical procedures.

K031564

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

for Mark N. Milliken

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

000009