(14 days)
Not Found
No
The summary describes a disposable electrosurgical scissor tip and its intended use for cutting and coagulation. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the physical components and function of the device.
No.
The device is used for cutting and coagulation of tissue, which are surgical procedures, not therapeutic ones.
No
The device description states its purpose is for "electrosurgical cutting and coagulation of tissue," which are treatment functionalities, not diagnostic ones.
No
The device description explicitly states it consists of "metal and polymer components" and is a physical disposable scissor tip used in conjunction with a reusable shaft and electrosurgical unit. This indicates it is a hardware device, not software-only.
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 "high frequency monopolar cutting and coagulation of tissue." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a surgical instrument used in conjunction with an electrosurgical unit.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not to perform surgical procedures directly on the body.
N/A
Intended Use / Indications for Use
The Switch-Blade® disposable scissor tips are supplied sterile and are intended for single use. The disposable scissor tips in conjunction with the reusable scissor shaft are intended to be connected to an Electrosurgical Unit via cables to allow high frequency monopolar cutting and coagulation of tissue.
Product codes
GEI
Device Description
The Switch-Blade® scissor tip product family consists of three configurations differing only in size and shape. The Switch-Blade® is supplied sterile in an individual Tyvek® pouch; six of these pouches are placed in 6 unit box (i.e. sales unit). The product is intended to be single use and is used in conjunction with catalog numbers 90-1050, 90-1150 or 90-1250 to achieve electrosurgical cutting and coagulation of tissue. The device consists of metal and polymer components.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K030890 i/3
APR 0 4 2003
Image /page/0/Picture/2 description: The image shows the logo for Snowden Pencer. The logo consists of the company name in a serif font, with the word "SNOWDEN" on the left and "PENCER" on the right. In between the two words is a graphic of several horizontal lines that are stacked on top of each other. There is a horizontal line underneath the entire logo.
Switch-Blade® Disposable Scissor Tips 510K pre-market notification Summary of Safety and Effectiveness
Purpose
This summary is intended to summarize content pursuant to CFR 21 part 807.92 of the Switch-Blade® Scissor Tips 510K Premarket Notification and the results of testing performed to show compliance with stated standards. Additionally the summary is intended to show significant equivalence with the predicate devices listed in this document.
Submitters Information
This Summary was created for Snowden Pencer Inc. on 27 February 2003 by the following individual:
David J. Booth Snowden Pencer Director of Quality Assurance and Regulatory Affairs
Contact Info:
Telephone 770-723-2741 Fax 770-723-2703 Email dbooth@snowdenpencer.com 089
Manufacturers Name, Address and Facility Registration Number
Snowden Pencer Inc. 5175 South Royal Atlanta Drive Tucker GA 30084
Facility registration number 1038548
Trade Name
Switch-Blade® Curved Metzenbaum Scissors 89-5100 Switch-Blade® Curved Mini-Metzenbaum Scissors 89-5300 Switch-Blade® Hook Scissors 89-5200
Common or Usual Name Sterile disposable (single use) electrosurgical scissor tip
Device Classification and Code
Class II - electrosurgical cutting and coagulation device and accessory (CFR 21 part 878.4400). Product Code GEI (see attachment III of this section for device listing)
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Ko30990 2/3
Predicate Devices
Statement of similarity
The Switch-Blade® remains essentially the same as the previously marketed version of this device in both function and indication for use. The Switch-Blade® is significantly equivalent to the Cooper Surgical (NU-TIP™), Micro Line("RE-NEW"), Aesculap (SOVEREIGN®), and Marlow (NU-TIP™)sterile electrosurgical scissor.
510K Table
The following table identifies the 510K number for the device Snowden Pencer wishes to use as predicate devices for purposes of this submission.
| Manufacturer | Cooper Surgical
(NU-TIP) | Aesculap
(SOVEREIGN®) | Micro Line ("RE-
NEW") | Marlow (NU-
TIP)** |
|--------------|-----------------------------|--------------------------|---------------------------|-----------------------|
| 510K # | Unknown * | K001330 | K962119 | Unknown ** |
| Product Code | GCJ | GEI | GEI | |
| Reg # | 876.1500 | 878.4400 | 878.4400 | |
- 510K could not be determined however medical device listing info is provided in attachment I of this section
** NU-TIP™ acquired from Marlow by Cooper Surgical
Description of Device
The Switch-Blade® scissor tip product family consists of three configurations differing only in size and shape. The Switch-Blade® is supplied sterile in an individual Tyvek® pouch; six of these pouches are placed in 6 unit box (i.e. sales unit). The product is intended to be single use and is used in conjunction with catalog numbers 90-1050, 90-1150 or 90-1250 to achieve electrosurgical cutting and coagulation of tissue. The device consists of metal and polymer components.
Indications for Use
Intended Use
The Switch-Blades® product is included in the indications for use of "Endoscopic Electrodes and Electrocautery Instruments" which are intended to be "connected to electrosurgical units via cable to allow monopolar cutting and coagulation". The intended use is contained in the Snowden Pencer Endoscopic Electrodes and Electrocautery Instruments IFU (instructions for use) document # 26-0188. The device IFU is further supplemented with a pictorial IFU contained in the disposable sale unit packaging document # 26 0043. Copies of these documents are provided in attachment II of this document
Technology Characteristics
The Switch-Blade® product functions on the well established methods/characteristics of monopolar high frequency electro-surgery as do all of its listed predicates. The performance/technological characteristics of the Switch-Blade® product and its predicates are dictated by national and international standard (i.e. 60601-2-2, 60601-2-18 and AAMI HF 18(same as 60601-2-18)) and are therefore the same.
090
2
030990 3/3
Conclusion
The Switch-Blade® product has a long history of safe and effective performance in the field. The proposed change in design and related change in sterilization method resultant from manufacturing improvement efforts has been fully and/or will be fully validated prior to product release. The Switch-Blade® product has been shown to be significantly equivalent to the aforementioned predicate devices. All testing dictated by various standards related to electrical safety (IEC 60601-2-2 and 606-1-2-18), biocompatibility (ISO 10993) and sterility assurance (11135) have been and/or will be performed prior to product release. (NOTE previous statements regarding have been and/or will be pricr to product release refer to sterility assurance activities related to the performance of validations in accordance with ISO 11135 i.e. load 3 testing)
Signed,
2/27/10
David J. Booth Quality Assurance and Regulatory Affairs Director
091
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 4 2003
Snowden Pencer, Inc. c/o Ms. Laura Danielson 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 New Brighton, Minnesota 55112-1891
Re: K030890
Trade/Device Name: Switch-Blade® Scissor Tips Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Devices Regulatory Class: II Product Code: GEI Dated: March 20, 2003 Received: March 21, 2003
Dear Ms. Danielson:
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.
4
Page 2 - Ms. Laura Danielson
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,
Miriam C. Provost
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
5
510(k) Number (if known): K030890
Device Name: Switch-Blade® Curved Metzenbaum Scissors 89-5100 Switch-Blade® Curved Mini-Metzenbaum Scissors 89-5300 Switch-Blade® Hook Scissors 89-5200
Indications For Use: The Switch-Blade® disposable scissor tips are supplied sterile and are intended for single use. The disposable scissor tips in conjunction with the reusable scissor shaft are intended to be connected to an Electrosurgical Unit via cables to allow high frequency monopolar cutting and coagulation of tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number --
(Optional Format 3-10-98)