(141 days)
Not Found
No
The summary describes a surgical accessory for cutting and coagulating tissue, with no mention of AI or ML capabilities, image processing, or data-driven performance metrics.
Yes.
The device is used in surgical procedures to cut and coagulate soft tissue, which directly treats a condition (e.g., diseased tissue or bleeding) during arthroscopic surgery.
No
Explanation: The device is described as an accessory for cutting and coagulating soft tissue during surgical procedures. There is no mention of it being used to diagnose conditions or gather diagnostic information.
No
The device description clearly states it is an "accessory device" designed to "fit directly over various sizes of straight automated debrider system blades" and is used to "cauterize tissue." This indicates a physical component that interacts with other hardware (debrider blades and ESUs), not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for cutting and coagulating soft tissue during surgical procedures. This is an in-vivo (within the living body) application, not an in-vitro (outside the living body) diagnostic test.
- Device Description: The description details how the device is used in conjunction with surgical debrider systems and ESUs to cauterize tissue. This further reinforces its use in a surgical setting.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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 various arthroscopic surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
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.
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)
Bench testing was conducted to determine device functionality and conformance to design input requirements.
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.
MSI Bipolar Sheath, K011202 Stryker Serfac K991960
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
1 of 2
Medical Scientific, Inc. 125 John Hancock Rd. Taunton, Ma. 02780 Tel: 508-880-7313 Fax: 508-880-7347
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
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.
-
- 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.
- Intended Use
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K031564 2 of 2
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- 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.
- Comparison of Technological Characteristics
-
- Performance Testing
Bench testing was conducted to determine device functionality and conformance to design input requirements.
- Performance Testing
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that form the shape of a person's head and torso.
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.
3
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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
4
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.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
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