Picker MR systems are intended for use as NMR devices that produce images that: (1) correspond to the distribution of protons exhibiting NMR, (2) devend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images vield information that can be useful in the determination of a diagnosis.

The Hammersmith Endocavitary Coils are indicated for use in the following anatomic regions and with the designated nuclei:

Anatomic Regions: The Anus or Prostate by insertion into the rectum, and the Cervix by insertion into the vagina Nuclei Excited: Hydrogen

Device Description

These three separate receive-only coils are for imaging the anus, prostate and cervix. The coils are designed to be inserted in either the rectum or vagina before imaging. The Hammersmith Endocavitary Coils are similar to the Philips Endo-Cavitary Coil in that they are reusable. However, unlike the Philips Endo-cavitary MRI Coil, they are rigid structures that do not contain an inflatable latex balloon. This difference in the design eliminates the need for limiting the number of times the Hammersmith Coils can be used, allows for fixed tuning and matching, and reduces the image artifacts due to susceptibility effects from air. Instead, the shape and dimensions of the Hammersmith Endocavitary Coils are similar to ultrasound probes used in endocavitary applications.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "Hammersmith Endocavitary Coils." It does not describe a study to prove acceptance criteria in the way an AI/ML device submission would. This submission focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway.

Therefore, many of the requested categories for AI/ML device studies are not applicable or cannot be extracted from this document, as it predates modern AI/ML medical device regulations and practices.

Here's a breakdown of what can be extracted and what cannot:

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

This document does not present acceptance criteria in the typical format of a performance study with quantitative metrics and thresholds. Instead, it demonstrates "substantial equivalence" based on various design and operational parameters compared to a predicate device.

Parameter	Hammersmith Endocavitary Coils	Predicate Device: Philips Endo-Cavitary MRI Coil (K930193)
Compatible MRI Systems	Picker Edge, Vista, Asset, Eclipse, Polaris and Apollo.	Philips Gyroscan ACS Series II and Gyroscan T5 series II systems.
Mode of Operation	Receive-Only.	Receive-Only.
Antenna Configuration	Linear.	Linear.
Tuning/Impedance Matching	Fixed tuning and matching. Factory set.	Tuned for each patient.
Method of Decoupling	Active diode decoupling.	Decoupling diode switch
Coil Enclosure	Rigid Acrylonitrile resin.	Flexible coil loop inside a non-permeable latex balloon.
Coil Stabilization	External immobilization positioning device.	Inflate balloon on coil with luer-lock syringe.
Number of Receive Channels	One.	One.
Cleaning and Disinfection Method	Cleaning: MetriZyme detergent. Disinfectant: Cidex Dip. Covered with sheath.	Cleaning: Detergent. Disinfectant: Cidex Dip. Covered with sheath.
Use Limits	None.	Used up to 50 times within one year of manufacturing.
Indications for use	Anus or Prostate by insertion into the rectum and Cervix by insertion into the vagina.	Prostate or Uterus by insertion into the rectum.
Contraindications	Any exclusion for a normal digital examination.	Severe hemorrhoids, recent surgery in the area of the rectum, inflammatory bowel disease, Crohn's disease and any exclusion for normal endorectal examinations.

Regarding "reported device performance": The document doesn't provide specific numerical performance metrics (e.g., signal-to-noise ratio, spatial resolution values) but rather asserts that the coil does not change the intended use of the Picker MR system and yields information that can be useful in the determination of a diagnosis when interpreted by a trained physician. The performance is implicitly "substantially equivalent" to the predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not describe a clinical study with a "test set" in the context of an AI/ML device. The "proof" of meeting acceptance criteria is through the substantial equivalence comparison to a legally marketed predicate device, not a performance study on a specific dataset.

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)

Not applicable. No "ground truth" establishment in the context of an AI/ML device evaluation is described. The device is a hardware component (an MRI coil).

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

Not applicable. No test set or adjudication process is described.

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 is not an AI-assisted device.

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

Not applicable. This is a hardware device (MRI coil), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No "ground truth" in the AI/ML sense is mentioned. The device's safety and effectiveness are established through demonstrating substantial equivalence to a predicate device.

8. The sample size for the training set

Not applicable. No training set is involved as this is a hardware device, not an AI/ML algorithm.

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

Not applicable. No training set or ground truth establishment is described.

Summary

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

K98 14/10

JUN 3 0 1998

SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)

1. General Information

Class II Classification: Magnetic Resonance Imaging (MRI) Accessory Common/Usual Name: Magnetic Resonance Imaging (MRI) Coil Hammersmith Endocavitary Coils Proprietary Name: Establishment Registration: Picker International, Inc. World Headquarters 595 Miner Road Highland Heights. Ohio 44143 FDA Owner Number: #1580240 FDA Registration Number: #1525965 Performance Standards: Not Applicable

Intended Uses

The Hammersmith Endocavitary Coils do not change the intended use of the Picker MR system with which they are used.

Picker MR systems are intended for use as NMR devices that produce images that: (1) correspond to the distribution of protons exhibiting NMR. (2) devend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images vield information that can be useful in the determination of a diagnosis.

The Hammersmith Endocavitary Coils are indicated for use in the following anatomic regions and with the designated nuclei:

Anatomic Regions: The Anus or Prostate by insertion into the rectum, and the Cervix by insertion into the vagina Nuclei Excited: Hydrogen

PICKER INTERNATIONAL, INC.

(ENDOCAV)

3/31/98

I - 1

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

Device Description 3.

Safety and Effectiveness 4.

The Picker Hammersmith Endocavitary Coils are substantially equivalent in safety and effectiveness to the Philips Endo-Cavitary MRJ Coil. The following chart has been compiled to demonstrate the substantial equivalence of these devices.

Parameter	Hammersmith EndocavitaryCoils	Predicate Device: Philips Endo-Cavitary MRI Coil (K930193)
Compatible MRISystems	Picker Edge, Vista, Asset, Eclipse,Polaris and Apollo.	Philips Gyroscan ACS Series IIand Gyroscan T5 series II systems.
Mode of Operation	Receive-Only.	Receive-Only.
AntennaConfiguration	Linear.	Linear.
Tuning/ImpedanceMatching	Fixed tuning and matching. Factoryset.	Tuned for each patient.
Method ofDecoupling	Active diode decoupling.	Decoupling diode switch
Coil Enclosure	Rigid Acrylonitrile resin.	Flexible coil loop inside a non-permeable latex balloon.
Coil Stabilization	External immobilization positioningdevice.	Inflate balloon on coil with luer-lock syringe.
Number of ReceiveChannels	One.	One.

PICKER INTERNATIONAL, INC.

(ENDOCAV)

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

Parameter	Hammersmith EndocavitaryCoils	Predicate Device: Philips Endo-Cavitary MRI Coil (K930193)
Cleaning andDisinfection Method	Cleaning: MetriZyme detergent.Disinfectant: Cidex Dip.Covered with sheath.	Cleaning: Detergent.Disinfectant: Cidex DipCovered with sheath.
Use Limits	None.	Used up to 50 times within oneyear of manufacturing.
Indications for use	Anus or Prostate by insertion intothe rectum and Cervix by insertioninto the vagina.	Prostate or Uterus by insertioninto the rectum.
Contraindications	Any exclusion for a normal digitalexamination.	Severe hemorrhoids, recentsurgery in the area of the rectum,inflammatory bowel disease,Crohn's disease and any exclusionfor normal endorectalexaminations.

I - 3

3/3 1/98

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

Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 1998

Elaine K. Keeler, Ph.D. Manager, MR Clinical Science Picker International, Inc. 595 Miner Road Highland Heights, Ohio 44143 Re:

K981410 Hammersmith Endocavitary Coils Dated: April 17, 1998 Received: April 20, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 MOS/90 LNH

Dear Dr. Keeler:

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 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 542 of the Act 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) 594-4613. 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 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/cdrb/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1198 1410 510(k) Number (if known):

Device Name: Hammersmith Endocavitary Coils

Indications for Use:

The Hammersmith Endocavitary Coils do not change the intended use of the Picker MR system with which they are used.

Picker MR systems are intended for use as NMR devices that produce images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Hammersmith Endocavitary Coils are indicated for use in the following anatomic regions and with the designated nuclei:

Anatomic Regions:

The Anus or Prostate by insertion into the rectum, and the Cervix by insertion into the vagina

Nuclei Excited:

Hydrogen

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Javid A. Segrin
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Devi

Radiological Devices
510(k) Number K981410

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.