(77 days)
Not Found
Not Found
No
The description details a simple peristaltic pump controlled by a potentiometer and foot pedal, with no mention of AI or ML terms or functionalities.
No
The device provides irrigation to rinse substances during surgical procedures, which is a supportive function rather than directly treating a disease or condition.
No
The device is described as an irrigation system used to rinse substances during endoscopic surgical procedures. Its function is to deliver sterile water or saline, not to detect, diagnose, or monitor a disease or condition.
No
The device description explicitly states that the system is comprised of a pump, foot pedal, and power cord, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To provide irrigation during endoscopic surgical procedures." This describes a device used during a surgical procedure to physically irrigate a site, not to perform a diagnostic test on a sample taken from the body.
- Device Description: The description details a pump system for delivering fluid for rinsing. This aligns with a surgical irrigation device, not a device that analyzes biological samples.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely mechanical and procedural.
N/A
Intended Use / Indications for Use
To provide irrigation during endoscopic surgical procedures
Product codes
KOG
Device Description
Spyglass is an invigation system for Endoscopy. This system is a peristaltic pump for delivering sterile water or saline through an endoscope (or catheter) for rinsing substances such as blood or bile from the procedural site. It is intended for open and endoscopic procedures.
The system is compromised of a pump, foot pedal, and power cord. The connection of the pumping unit to the foot pedal and fluid supply provides the user with a system capable of producing a broad range of pressures. This is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. An electrically activated foot pedal controls the, running or stopping of the pump motor. The footswitch provide continuous flow when pressed.
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
Bench testing was performed to demonstrate that the Spyglass Irrigation would perform as intended.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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K07/832
Page 1 of 2
SEP 1 8 2007
510(k) Summary of Safety and Effectiveness Medical Scientific Corporation Spyglass Irrigation System June 27, 2007
- Sponsor Name
Sponsor/Manufacturer: Medical Scientific Corporation 125 John Hancock Blvd Taunton, MA 02780 Tel: 508 880 7313 Fax: 508 880 7347
2. Device Name
Proprietary Name: Spyglass Irrigation System Common/Usual Name: Endoscope and accessories
Panel: Gastroenterology and Urology Product Code: KOG
-
- Identification of Predicate or Legally Marketed Device
-
- Device Description
Spyglass is an invigation system for Endoscopy. This system is a peristaltic pump for delivering sterile water or saline through an endoscope (or catheter) for rinsing substances such as blood or bile from the procedural site. It is intended for open and endoscopic procedures.
The system is compromised of a pump, foot pedal, and power cord. The connection of the pumping unit to the foot pedal and fluid supply provides the user with a system capable of producing a broad range of pressures. This is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. An electrically activated foot pedal controls the, running or stopping of the pump motor. The footswitch provide continuous flow when pressed.
- న్న Intended Use To provide irrigation during endoscopic surgical procedures
-
- Comparison of Technological Characteristics The comparison of Intended Use, System Components, Flow rate adjustments, Min/max flow rate, Min/max Pressures, and Pump Type indicate the device is substantially equivalent to its predicate.
1
K071832
Page zajz
Performance Testing 7 Bench testing was performed to demonstrate that the Spyglass Irrigation would perform as intended.
-
- Statement of Equivalency
The Spyglass Irrigation System is substantially equivalent to the predicate devices. The intended use, technological characteristics of the materials and processes used in the application and safety characteristics of the Spyglass Irrigation System support the concept of substantial equivalence
- Statement of Equivalency
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure, possibly representing an eagle or other national symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 1 8 2007
Paul Nardella, Jr. President Medical Scientific Corporation Taunton Corporate Center 125 John Hancock Road TAUNTON MA 02780
Re: K071832
Trade/Device Name: Modification to the SpyGlass™ Irrigation System Regulation Number: None Regulatory Class: Unclassified Product Code: LJH Dated: August 17, 2007 Received: August 30, 2007
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image is a circular seal with the letters "FDA" in the center. Above the letters, the number "FDX-3005" is printed. Below the letters, the word "Centennial" is printed, along with three stars. The text around the edge of the seal is difficult to read due to the image quality.
3
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.
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 one of the following numbers, based on the regulation number at the top of this letter:
21 CFR 876.xxxx 21 CFR 884.xxxx 21 CFR 892.xxxxx Other
(Gastroenterology/Renal/Urology) 240-276-0115 (Obstetrics/Gynecology) (Radiology);
240-276-0115 240-276-0120 240-276-0100
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K071832
Page 1 of 1
K071832 510(k) Number (if known):
Device Name: Spyglass Irrigation System
Indications For Use:
To provide irrigation during endoscopic surgical procedures
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
570(k) Number K071832
000010