Daig SpyglassTM angiographic catheters are radiopaque polymer reinforced with braided stainless steel. This construction yields a small diameter catheter, which retains strength and high flow rate capabilities. A soft atraumatic tip provides good memory and protects against vessel damage. Preformed tip shapes matching or complementing specific anatomy allow access into a variety of vessels.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the SpyglassTM 5Fr Angiographic Catheter. It outlines similarities to predicate devices to establish substantial equivalence for regulatory approval. However, it does not contain any information regarding acceptance criteria, study performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Manufacturers are required to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and the same technological characteristics as the predicate, or that if there are differences, these differences do not raise new questions of safety or effectiveness.

Therefore, based on the provided document, I cannot complete the table or answer most of the questions as the specific details of a performance study are not present.

Here's what can be inferred from the document regarding the "study" for acceptance, which in this context is a comparison to a predicate device:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Identical intended use to predicate device	Met: "The Daig SpyglassTM angiographic catheters are designed for delivery of radiopaque contrast media during angiographic procedures." (Matches predicate's likely use)
Identical technological characteristics to predicate device	Met: "All technological characteristics of the Spyglass™ 5Fr Angiographic Catheter are identical to the predicate device (K962805) including product design, packaging, sterilization, and labeling."
No new questions of safety or effectiveness raised by differences	Met: The FDA's letter of clearance (K982299) indicates substantial equivalence, implying no new safety/effectiveness concerns were identified.

2. Sample sized used for the test set and the data provenance:

Sample Size: Not applicable. This submission relies on a comparison of characteristics to a predicate device, not a new clinical performance study with a test set of patients/data.
Data Provenance: Not applicable for a typical "test set." The basis of comparison is the existing predicate device's characteristics and historical performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The ground truth here is derived from the established safety and effectiveness of the predicate device, not through expert consensus on a new test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable.

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:

No. This is a medical catheter, not an AI diagnostic device. MRMC studies are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a physical medical device.

7. The type of ground truth used:

Predicate Device Equivalence: The "ground truth" for this 510(k) submission is the pre-existing FDA clearance and established safety/effectiveness profile of the predicate Spyglass™ Angiographic Catheter family (K944284, K962805, and K965249). The new device is deemed safe and effective because it is substantially equivalent to these already approved devices.

8. The sample size for the training set:

Not applicable. This is not a machine learning model.

9. How the ground truth for the training set was established:

Not applicable.

Summary

{0}------------------------------------------------

OCT 1 9 1998

510(k) Summary _______________________________________________________________________________________________________________________________________________________________

510(k) Summary (As required by 21 CFR 807.92)

A. Submitter Information

Submitter's Name	Daig Corporation, a St. Jude Medical Company
Address	14901 DeVeau PlaceMinnetonka, Minnesota 55345-2126 U.S.A.
Telephone Number	(612) 933-4700
Contact Person	Michael G. Schultz
Submission Prepared	June 30, 1998
Device Information
Common or Usual Name	SpyglassTM 5Fr Angiographic Catheter
Classification Name	Angiographic Catheter
Predicate Device	SpyglassTM Angiographic Catheter Family(K944284, K962805, and K965249)
Device Description	Daig SpyglassTM angiographic catheters are radiopaquepolymer reinforced with braided stainless steel. Thisconstruction yields a small diameter catheter, which retainsstrength and high flow rate capabilities. A soft atraumatictip provides good memory and protects against vesseldamage. Preformed tip shapes matching or complementingspecific anatomy allow access into a variety of vessels.
Intended Use	The Daig SpyglassTM angiographic catheters are designedfor delivery of radiopaque contrast media duringangiographic procedures.

C. Comparison of Required Technological Characteristics

All technological characteristics of the Spyglass ™ 5Fr Angiographic Catheter are identical to the predicate device (K962805) including product design, packaging, sterilization, and labeling.

{1}------------------------------------------------

510(k) Summary________________________________________________________________________________________________________________________________________________________________

Support of the Substantial Equivalence D.

Daig Corporation considers the Spyglass™ 5Fr Angiographic Catheter to be substantially equivalent to the following predicate devices: Spyglass™ Angiographic Catheter (formerly called Control™ Angiographic Catheter) received marketing clearance on March 3, 1995 (K944284) and Spyglass™ Angiographic Catheter received marketing clearance on October 28, 1996 (K962805).

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 19 1998

Mr. Michael G. Schultz Quality Systems Manager DAIG Corporation 14901 Deveau Pl. Minnetonka, MN 5345-2126

Re: K982299 5FR Spyglass™ Angiographic Catheter Trade Name: Regulatory Class: II Product Code: DOO Dated: September 25, 1998 Received: September 28, 1998

Dear Mr. Schultz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act

{3}------------------------------------------------

Page 2 - Mr. Michael G. Schultz

for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

			more was------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
--	--	--	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

510(k) Number (if known):	K98 2299
---------------------------	----------

5Fr Spyglass™ Angiographic Catheter __________________________________________________________________________________________________________________________________________ Device Name:

Indications for Use:

. •

The 5Fr Spyglass™ Angiographic Catheter is designed for delivery of radiopaque contrast media during angiographic procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature
(Division Sign-Off)

Division of Cardiovascular, Respiratory,

and Neurological Devices

510(k) Number	K982299
---------------	---------

Prescription Use(Per 21 CFR 801.109)		OR	Over-The-Counter Use(Optional Format 1-2-96)
------------------------------------------	-----------------------------------------------------------	----	--------------------------------------------------

105

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).