Spyglass is an irrigation 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.

AI/ML Overview

Here's an analysis of the provided text regarding the Spyglass Irrigation System's acceptance criteria and study, structured to address your specific points:

The provided 510(k) summary for the Spyglass Irrigation System offers very little detail regarding specific acceptance criteria or a comprehensive study demonstrating direct performance against those criteria. It primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Specific criteria (e.g., flow rate accuracy, pressure range, sterility, safety features, durability, ease of use with endoscope)	Not explicitly stated. The document broadly mentions "perform as intended" and "demonstrate substantial equivalence."
Predicate Device Performance Reference	Implicitly, the device performance is deemed acceptable if it matches or is comparable to the predicate device in terms of: - Intended Use - System Components - Flow rate adjustments - Min/max flow rate - Min/max Pressures - Pump Type

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not mentioned. The document only states "Bench testing was performed." It doesn't specify if this involved multiple devices, repeated trials, or a representative sample.
Data Provenance: Not mentioned. Given the nature of a 510(k) submission and "bench testing," it's highly likely to be internal R&D data from the manufacturer (Medical Scientific Corporation) in the USA. It is prospective testing, as it's for premarket notification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable/Not mentioned. The testing described is "bench testing," which typically involves objective measurements by engineers or technicians against specifications, rather than expert judgment for ground truth.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving interpretation of data (e.g., medical images) by multiple experts. The described testing is bench testing, which doesn't involve this type of adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The document focuses on technical bench testing and comparison to a predicate device, not on assessing human reader improvement with or without AI assistance. The device is an irrigation pump, not an AI-assisted diagnostic tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, in a sense, a standalone evaluation was performed through "bench testing." This type of testing assesses the device's technical specifications and functionality independent of direct human operational variables beyond standard use. However, it's not an "algorithm only" study as the device is mechanical/electronic, not AI-driven.

7. Type of Ground Truth Used

Bench Test Specifications/Predicate Device Data: The ground truth for the bench testing would be the pre-defined technical specifications for flow rate, pressure, and operational parameters, often benchmarked against the predicate device's known performance characteristics.

8. Sample Size for the Training Set

Not applicable/Not mentioned. The Spyglass Irrigation System is a medical device, not an AI/machine learning algorithm, so it doesn't have a "training set" in the conventional sense of data used to train a model.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there's no training set for this type of device, no ground truth needed to be established for it.

Summary of Study limitations based on the provided text:

The provided document (a 510(k) summary) is very high-level and intentionally brief. It aims to demonstrate substantial equivalence, not to provide a detailed report of all validation testing. Key information regarding specific performance metrics, the methodology of the "bench testing," sample sizes, and detailed acceptance criteria are omitted for brevity in this public summary. Such details would be present in the full 510(k) submission, which is not publicly available in this format.

Summary

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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

1. Identification of Predicate or Legally Marketed Device
1. 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
1. 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.

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K071832
Page zajz

Performance Testing 7 Bench testing was performed to demonstrate that the Spyglass Irrigation would perform as intended.

1. 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

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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.

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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)

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

Regulation Number and Section

§ 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.