(57 days)
To provide irrigation during endoscopic surgical procedures
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 a sterile single use disposable tubing set. 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. The pump provides an adjustable flow-rate from 0 - 45 ml/min at 45 psi. 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. The tubing set will mate with a standard bottle of sterile water or saline and is provided sterile. A portion of the tubing set is placed in the peristaltic pump for flow creation.
The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study report with quantitative performance data for the SpyGlass Irrigation System.
The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive performance study details as might be found in a full clinical trial report or engineering validation document.
Here's what can be extracted and what is missing based on your template:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | "To provide irrigation during endoscopic surgical procedures" (Matched to predicate) |
| System Components | Matched to predicate |
| Flow rate adjustments | Matched to predicate |
| Min/max Pressures | Matched to predicate |
| Pump Type | Matched to predicate |
Missing: Specific numerical values for flow rate ranges, pressure ranges, or other quantifiable performance metrics are not detailed in this summary. The acceptance criteria essentially appear to be "substantially equivalent to the predicate device" in these identified characteristics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing. The document only states "Performance Testing: Information presumed to demonstrate that the Spyglass Irrigation would perform as intended." It does not describe any specific test set, sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Missing. No information on expert involvement or ground truth establishment is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing. No information on adjudication methods is provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable. This device is an irrigation system, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a hardware irrigation system, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing. The concept of "ground truth" as typically applied to AI or diagnostic studies is not directly applicable or discussed for this irrigation hardware device. Performance would likely be evaluated against engineering specifications and predicate device performance.
8. The sample size for the training set
Missing. No training set is mentioned as this is a hardware device, not a machine learning model.
9. How the ground truth for the training set was established
Not Applicable. See point 8.
Summary of the Study (Based on the Provided Text):
The document submitted for the SpyGlass Irrigation System (K063700) is a 510(k) summary. The primary "study" or justification presented is a comparison of technological characteristics to demonstrate substantial equivalence to predicate devices (Endogator Endoscopy Irrigation Pump - K060962, K031773).
The comparison covered:
- Intended Use
- System Components
- Flow rate adjustments
- Minimum/maximum Pressures
- Pump Type
The statement "Performance Testing: Information presumed to demonstrate that the Spyglass Irrigation would perform as intended" indicates that some internal testing was conducted, but the details of this testing (e.g., methodology, results, data, sample sizes, specific acceptance criteria beyond "performs as intended") are not included in this public 510(k) summary. The FDA's letter confirms that based on the information provided, the device was found substantially equivalent to predicate devices.
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Medical Scientific Corporation 510(k) Premarket Notification
SpyGlass Irrigation System
K063700
510(k) Summary of Safety and Effectiveness Medical Scientific Corporation Spyglass Irrigation System December 1, 2006
8 2007 FEB
Sponsor Name 1. Sponsor/Manufacturer: Medical Scientific Corporation 125 John Hancock Blvd Taunton, MA 02780 Tel: 508 880 7313 Fax: 508 880 7347
Device Name 2.
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 3. Endogator Endoscopy Irrigation Pump - K060962, K031773
Device Description 4.
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 a sterile single use disposable tubing set. 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. The pump provides an adjustable flow-rate from 0 - 45 ml/min at 45 psi. 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. The tubing set will mate with a standard bottle of sterile water or saline and is provided sterile. A portion of the tubing set is placed in the peristaltic pump for flow creation.
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K06 3700
Page 2 of 2
- Intended Use રું. To provide irrigation during endoscopic surgical procedures
- Comparison of Technological Characteristics б. The comparison of Intended Use, System Components, Flow rate adjustments, The comparison of Min/max Pressures, and Pump Type indicate the device is substantially equivalent to its predicate.
- Performance Testing 7 I crormation resumed to demonstrate that the Spyglass Irrigation would perform as intended.
- Statement of Equivalency 8. 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
000079
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 an abstract symbol that resembles a stylized human figure.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Paul Nardella, Jr. President Medical Scientific, Inc. Taunton Corporate Center 125 John Hancock Road TAUNTON MA 02780
FEB 8 2007
Re: K063700
Trade/Device Name: SpyGlass™ Irrigation System Regulation Number: None Regulatory Class: Unclassified Product Code: LJH Dated: December 1, 2006 Received: December 13, 2006
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 text "1906-2006" at the top. The letters "FDA" are in the center of the seal, with the word "Centennial" underneath. The seal is surrounded by text that reads "U.S. FOOD & DRUG ADMINISTRATION PROTECTING YOUR HEALTH".
Protecting and Promoting Public Health
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Page 2 -
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely yours,
Nancy Cbrogdon
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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Indications for Use
K06 3700
510(k) Number (if known): K063700 -
Spyglass Irrigation System Device Name:
Indications For Use:
To provide irrigation during endoscopic surgical procedures
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEBDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Wyman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_
§ 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.