Device Name	Indications
Guglielmi Detachable Coils (GDC®)	For embolizing certain intracranial aneurysms that - because of their morphology, their location, or thepatient's general medical condition - are considered by the treating neurosurgical team to be a) very highrisk for management by traditional operative techniques, or b) inoperable; and for embolizing othervascular malformation such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The GDC is also intended for arterial and venous embolizations in the peripheralvasculature.
Occlusion Coils:
Fibered Platinum Coil, .035" Type	For arterial and venous embolizations in the peripheral vasculature
Berenstein Liquid Coil	For the embolization of vascular malformations of the peripheral, coronary and neuro vasculature.
Occlusion Coils (except FiberedPlatinum Coil .035" Type andBerenstein Liquid Coil)	Coils are intended to obstruct or reduce blood flow in the peripheral and neurovasculature. They areintended for use in the interventional radiologic management of arteriovenous malformations andarteriovenous fistulas when devascularization prior to definitive surgical resection is desirable.
Guidewires	Target Therapeutics Steerable Guidewires are designed to assist in the delivery of Tracker InfusionCatheters to selected vascular sites.
Tracker® Infusion Catheter	Tracker Infusion Catheters are designed to assist in the delivery of diagnostic agents, such as contrastmedia, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, andneurovasculature.
Stealth® Dilation Catheter	The Stealth Dilation Catheter System is intended for the dilatation of peripheral vasculature (PTA). Thisdevice is not intended for use in the coronary arteries.
Coil Pusher	The coil pusher is a guidewire-like device consisting of a stainless steel wire with a radiopaque goldmarker at its tip. The coil pusher is intended to be used by the physician in deploying the coil to the site.
Guidewire Introducer	The guidewire introducer consists of a cannula and luer used to introduce guidewires into catheter hubsor hemostatic valves.
Guidewire Torquer	The guidewire torquer was developed to enhance control of torqueable guidewires during intravascularplacement.
Rotating Hemostatic Valve	To maintain a fluid tight seal at the point of entry when a guiding catheter or sheath is used to support theplacement of a therapeutic or diagnostic catheter.
Shaping Mandrel	The Shaping Mandrel is a stainless steel accessory device used by physicians to form or shape acatheter tip to suit the requirements of a particular case.
Valve Wire	The Valve Wire is used in conjunction with Stealth balloon dilatation catheters to seal the distal end of theballoon section enabling it to be inflated.

Device Description

Please refer to Table 1 (Page 10)

AI/ML Overview

The provided text is a 510(k) summary for various medical devices by Target Therapeutics. It primarily focuses on demonstrating substantial equivalence to predicate devices based on functional, chemical, biocompatibility, and sterile barrier tests.

This document does not contain information on acceptance criteria and a study that proves the device meets those criteria in the context of AI/ML performance.

Instead, it details laboratory-based testing for physical and chemical properties and refers to section 6 of the submission for further details on these tests. There is no mention of a study involving human readers, ground truth established by experts, or AI performance metrics.

Therefore, I cannot fulfill your request for information related to AI/ML acceptance criteria and studies based on the provided text. The document is for a traditional medical device submission, not an AI/ML-driven one.

Summary

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K971395
July 14, 1997

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS, CLASS III CERTIFICATION STATEMENT, CERTIFICATION OF IDENTICAL MATERIALS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

a) Summary of Safety and Effectiveness

CONTACT PERSON:

Roxane Baxter Manager, Regulatory Affairs Target Therapeutics, Inc. 47201 Lakeview Blvd. Fremont, CA 94538-6530

DEVICE NAMES:

Please refer to Table 1 (Page 10)

DEVICE DESCRIPTIONS:

Please refer to Table 1 (Page 10)

INDICATIONS FOR USE:

Please refer to Table 2 (Pages 13 and 14)

PREDICATE DEVICES:

· Guglielmi Detachable Coil K962503
· GUIDEWIRES
Dasher K950069, K915115
Taper K924987, K880762
Seeker K912293, K922912
Stubbie K912293
· OCCLUSION COILS
Fibered Platinum Coil, .035" Type K955293
Berenstein Liquid Coil K964112
Occlusion Coils K914786
· TRACKER Infusion Catheters K925813
· STEALTH Dilatation Catheters K915895
· ACCESSORIES
Rotating Hemostatic Valve K873971
Guidewire Introducer K873972
Guidewire Torquer K860840
Coil Pusher K911779, K891688
Shaping Mandrel K951159
Valve Wire K915895, K90428

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TESTING in SUPPORT of SUBSTANTIAL EQUIVALENCE DETERMINATION:

Table 1 summarizes the testing done in support of a determination of substantial equivalence. Testing in support of this submission may be found in Section 6 beginning on page 37.

Product Family	FunctionalTests	Chemical Degradation /Biocompatibility Tests	Sterile Barrier Test
GuglielmiDetachable Coil(GDC®)	• Visual / DimensionalInspection• Detachment Time• Bushing Leak Test• Tensile StrengthReference Section 6E,Page 118	FTIR spectragraphsgenerated for:• Dacron Fiber• PTFE Bushing• Teflon SprayReference Section 6E,Page 119 and 125	Packaging Integrity /Microbial Challenge Test(Tracker-18 used forrepresentative productpackaging)Reference:Section 6E, Page 119 andSection 6F, Page 130
Occlusion Coils	• Visual / DimensionalInspection• Fiber IntegrityReference Section 6D,Page 106	FTIR spectragraphgenerated for:• Dacron FiberReference Section 6D,Page 107 and 114	Packaging Integrity /Microbial Challenge Test(Tracker-18 used forrepresentative productpackaging)Reference:Section 6D, Page 107 andSection 6F, Page 130
Tracker InfusionCatheters	• Visual / DimensionalInspection• Tip Flexibility• Static Rupture• Tensile Strength• Coating IntegrityReference Section 6B,Page 65	FTIR spectragraphsgenerated for:• Polyethylene• Polyethylene w/Silicone Coating• Silicone Coating• Polypropylene• Polycarbonate Hub• Polyurethane LuerFitting• Polycarbonate RHVReference Section 6B,Page 67 and 76	Packaging Integrity /Microbial Challenge Test(Tracker-18 used forrepresentative productpackaging)Reference:Section 6B, Page 67 andSection 6F, Page 130

Table 1
Summary of Tests - By Product or Product Family

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Table 1 (cont.) Summary of Tests - By Product or Product Family

Product Family	FunctionalTests	Chemical Degradation /Biocompatibility Tests	Sterile Barrier Test
STEALTH BalloonDilatation Catheters	• Visual / DimensionalInspection• Static Rupture• Valve Wire Sealing• Silicone CoatingIntegrityReference Section 6C,Page 90	FTIR spectragraphsgenerated for:• Silicone Coating• Polyethylene- distal shaft- proximal shaft- balloon tubingReference Section 6C,Page 90 and 99	Packaging Integrity /Microbial Challenge Test(Tracker-18 used forrepresentative productpackaging)Reference:Section 6C, Page 90 andSection 6F, Page 130
Guidewires	• Visual / DimensionalInspection• Tip Stiffness• Tensile Strength• Turns to Failure• Teflon Adhesion- Spray coating- Laminated tubingReference Section 6A,Page 39	FTIR spectragraphsgenerated for:• Teflon Spray Coating• Teflon Tubing,Laminated• Silicone CoatingReference Section 6A,Page 41 and 59	Packaging Integrity /Microbial Challenge Test(Tracker-18 used forrepresentative productpackaging)Reference:Section 6A, Page 41 andSection 6F, Page 130
Accessories
Guidewire Torquer	• Visual / DimensionalInspection• ComponentCompatibility Test• Grip TestReference Section 6A,Page 40	N/A - no body contact	Packaging Integrity /Microbial Challenge Test(Tracker-18 used forrepresentative productpackaging)Section 6F, Page 130
Guidewire Introducer	• Visual / DimensionalInspection• Introducer Pull TestReference Section 6A,Page 40	N/A - no body contact	Packaging Integrity /Microbial Challenge Test(Tracker-18 used forrepresentative productpackaging)Section 6F, Page 130
Product Family	FunctionalTests	Chemical Degradation /Biocompatibility Tests	Sterile Barrier Test
Accessories (cont.)Rotating HemostaticValve	• Visual / DimensionalInspectionReference Section 6B,Page 84	FTIR spectrographgenerated for:• PolycarbonateReference Section 6B,Page 84 and 94	Packaging Integrity /Microbial Challenge Test(Tracker-18 used forrepresentative productpackaging)Reference:Section 6F, Page 130
Shaping Mandrel	Covered under testingdone for guidewires.Reference Section 6A,Page 66	Covered under testingdone for guidewires.Reference Section 6A.	"
Valve Wire	Covered under testingdone for guidewires.Reference Section 6A.	FTIR spectrographsgenerated for:• Teflon coating• Silicone coatingCovered under testingdone for guidewires.Reference Section 6A.	"
Coil Pushers	• Visual / DimensionalInspection• Tip Stiffness• Tensile Strength• Turns to Failure• Teflon Adhesion- Spray coating- Laminated tubingReference Section 6A,Page 39	FTIR spectrographgenerated for:• Teflon coatingCovered under testingdone for guidewires.Reference Section 6A.	"

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Table 1 (cont.) Summary of Tests - By Product or Product Family

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Roxane Baxter Manager, Regulatory affairs Target Therapeutics 47201 Lakeview Boulevard Fremont, California 94538-6530

JUL 14 1997

K971395 Re: Various Class II and Class III devices (add shelf life) Requlatory Class: II and III (Two and Three) Product Codes: 74 DQX, 74 GBK, 74 LIT, 74 KRD, 74 DYG, and 84 HCG Dated: April 14, 1997 Received: April 15, 1997

Dear Ms. Baxter:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Fractice requirements, as set forth in the Quality System Regulation (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 Reqister. 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

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Page 2 - Ms. Roxane Baxter

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 (i.e., with a shelf life of either 36 or 50 months, depending on the device). 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) 594-4648. 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" (21 CFR 807.97). Other qeneral 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/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

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Page_1__of_1

TARGET THELAPEUTIC

510(k) Number (if known): K971395 Device Name: See table below

Indications For Use: See table below

Device Name	Indications
Guglielmi Detachable Coils (GDC®)	For embolizing certain intracranial aneurysms that - because of their morphology, their location, or thepatient's general medical condition - are considered by the treating neurosurgical team to be a) very highrisk for management by traditional operative techniques, or b) inoperable; and for embolizing othervascular malformation such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The GDC is also intended for arterial and venous embolizations in the peripheralvasculature.
Occlusion Coils:
Fibered Platinum Coil, .035" Type	For arterial and venous embolizations in the peripheral vasculature
Berenstein Liquid Coil	For the embolization of vascular malformations of the peripheral, coronary and neuro vasculature.
Occlusion Coils (except FiberedPlatinum Coil .035" Type andBerenstein Liquid Coil)	Coils are intended to obstruct or reduce blood flow in the peripheral and neurovasculature. They areintended for use in the interventional radiologic management of arteriovenous malformations andarteriovenous fistulas when devascularization prior to definitive surgical resection is desirable.
Guidewires	Target Therapeutics Steerable Guidewires are designed to assist in the delivery of Tracker InfusionCatheters to selected vascular sites.
Tracker® Infusion Catheter	Tracker Infusion Catheters are designed to assist in the delivery of diagnostic agents, such as contrastmedia, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, andneurovasculature.
Stealth® Dilation Catheter	The Stealth Dilation Catheter System is intended for the dilatation of peripheral vasculature (PTA). Thisdevice is not intended for use in the coronary arteries.
Coil Pusher	The coil pusher is a guidewire-like device consisting of a stainless steel wire with a radiopaque goldmarker at its tip. The coil pusher is intended to be used by the physician in deploying the coil to the site.
Guidewire Introducer	The guidewire introducer consists of a cannula and luer used to introduce guidewires into catheter hubsor hemostatic valves.
Guidewire Torquer	The guidewire torquer was developed to enhance control of torqueable guidewires during intravascularplacement.
Rotating Hemostatic Valve	To maintain a fluid tight seal at the point of entry when a guiding catheter or sheath is used to support theplacement of a therapeutic or diagnostic catheter.
Shaping Mandrel	The Shaping Mandrel is a stainless steel accessory device used by physicians to form or shape acatheter tip to suit the requirements of a particular case.
Valve Wire	The Valve Wire is used in conjunction with Stealth balloon dilatation catheters to seal the distal end of theballoon section enabling it to be inflated.

(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 Cardiovascular. Respiratory, and Neurological Devices

510(k) Number_k 471395

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.