Endoscopically Deliverable Ultrasound Point Probe System (SP-701) with transducers PL-1726-20, PL-1726-15, PL-1726-12, PL-1926-20, PL-1926-15, PL-1926-12, PL-2226-20, PL-2226-15, PL-2226-12.

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Fuginon, Inc. regarding their Endoscopically Deliverable Ultrasound Point Probe System (SP-701). This document approves the device for marketing based on substantial equivalence to previously marketed devices. However, it does not contain a study that proves the device meets acceptance criteria. Instead, it outlines the regulatory classification and general controls, and importantly, requires a post-clearance special report with acoustic output measurements based on production line devices. This means the specific performance data for acceptance criteria would be generated after this clearance, not before this document was issued.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method for the test set
Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size
Standalone (algorithm only) performance study results
Type of ground truth used
Sample size for the training set
How the ground truth for the training set was established

The document primarily focuses on the regulatory clearance process rather than detailed performance study results. The closest information related to performance acceptance is the requirement for a post-clearance special report containing acoustic output measurements, which implicitly suggests that certain acoustic output levels would need to be met for the production units to be considered compliant.

Summary of available information:

Device: Endoscopically Deliverable Ultrasound Point Probe System (SP-701) with various transducers.
Regulatory Status: Substantially equivalent to previously marketed devices (K971528).
Key Requirement Post-Clearance: Submission of a "post-clearance special report" including "complete information, including acoustic output measurements based on production line devices." This indicates that performance data, specifically acoustic output, is a critical aspect for ensuring compliance after initial clearance.
Intended Use: Diagnostic ultrasound imaging or Doppler analysis of the human body, specifically for Intra-luminal applications across all listed transducers (PL-1726-20, PL-1726-15, PL-1726-12, PL-1926-20, PL-1926-15, PL-1926-12, PL-2226-20, PL-2226-15, PL-2226-12). For transducers PL-2220-20 and SP-701 Transducer P1-1926-12, they state only "Intra-luminal" (not A or B mode).

No study details are provided in this document regarding how the device initially met any acceptance criteria to establish substantial equivalence, other than the general statement of "reviewed your section 510(k) notification...and we have determined the device is substantially equivalent."

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the bird symbol.

DEC 1 2 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gary A. Adler Fuginon, Inc. c/o Marks and Murase 399 Park Avenue New York, NY 10022-4689 Re: K971528 Endoscopically Deliverable Ultrasound Point Probe System (SP-701) Dated: September 19, 1997 Received: September 19, 1997 Regulatory Class: II 21 CFR 892.1560/Procode: 90 IYO 21 CFR 892.1570/Procode: 90 ITX 21 CFR 892.1500/Procode: 78 KOG

Dear Mr. Adler:

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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the Encoscopically Deliverable Ultrasound Point Probe System (SP-701), as described in your premarket notification:

Transducer Model Number

PL-1726-20	PL-1726-15	PL-1726-12	PL-1926-20
PL-1926-15	PL-1926-12	PL-2226-20	PL-2226-15
PL-2226-12

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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that; through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

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Page - 2 - Mr. Gary A. Adler

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your 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 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) 594-4591. 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 at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Paul Gammell, Ph.D., at (301) 594-1212.

Sincerely yours,

William Yin

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

Enclosure(s)

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1971528 510(k) Number (دي known) . Bliverable Ultrasound Point Probe System Device Name: SP-701

Fill our one form for each ultrasound system or transducer.

Diagnostic ultrasound imaging or Doppler analysis Indications For Use: (Specify) of the human body as follows:

Hode of Operation

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Total
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
NeonatalCephalic
Adult Cephalic
Cardiac Adult
CardiacPediatric
Trans-esophageal
Trans-rectal
Trans-vaginal
Intra-luminal		X
Trans-urethral
Peripheralvessel
Laparoscopic

PLEASE DO NOT WRITE BELOW THIS LINE-OFFICE OR AGENCY BANK IT (FEDERAL)

Comments of CDR, Steffen at Purdue Polytechnic (153)

William Ym
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Deyices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

K-1

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	8971528
	510(k) Number if known) : 20 MHz Transducer
	Company of the country of the count of the contribution of the commend of the management of the manufactures of

Fill our one form for each ultrasound system or cransducer.

Diagnostic ultrasound imaging or Dopplar analysis Indications For Use: (Spacify) of the human body as follows: Hode of Operation

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
NeonatalCephalic
Adult Cephalic
Cardiac Adult
CardiacPediatric
Trans-esophageal
Trans-rectal
Trans-vaginal
Intra-luminal		X
Trans-urethral
Peripheralvessel
Laparoscopic

PLEASE DO MOT VRETT EFLOW THIS of C

William Yri

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De

510(k) Number K971528

Prescription Use (Per 21 CFR 801.109)

K-1

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Ultrasound Device Indications Statement Page

K971528
510 (k) Number : if known) : _________________________________________________________________________________________________________________________________________________
15 MHz TransducerDevice Name: SP-701 PL1726-15

Fill our one form for each ultrasound system or cransducer.

Diagnostic ultrasound imaging or Doppler analysis Indications For Use: (Specify) of the human body as follows:

Mada of Operation

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
NeonatalCephalic
Adult Cephalic
Cardiac Adult
CardiacPediatric
Trans-esophageal
Trans-rectal
Trans-vaginal
Intra-luminal		X
Trans-urethral
Peripheralvessel
Laparoscopic

LET DATE DO MOT WELLER BERLON THE CHE CHER CHEFFECT CAL . . . . . . . . . . . . . .

William Y

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

K-1

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	8971528510(k) Number if known): ___	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Device Name: __	Comments of Children Comments of Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children ChildrPL=1726-12SP-701	12 MHZTransducer

Fill out one form for each ultrasound system or cransducer.

Diagnostic ultrasound imaging or Doppler analysis Indications For Use: (Specify) of the human body as follows:

Mode of Operation

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
NeonatalCephalic
Adult Cephalic
Cardiac Adult
CardiacPediatric
Trans-esophageal
Trans-rectal
Trans-vaginal
Intra-luminal		X
Trans-urethral
Peripheralvessel
Laparoscopic

OPLEASE DO OF VELTY 395.09 THIS LINE . CONTINUT ON ANOTHER PAGE IT I .! CORE, Office

William Yi

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev

510(k) Number

X-1

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	1971528510 (k) Number if known) : ___________________________________________________________________________________________________________________________________________________Transducer20 MHz
Device Name:	PL-1926-20SP-701and and a many and the many of the many of the many of the many of

Fill out one form for each ultrasound system or cransducer.

Diagnostic ultrasound imaging or Doppler analysis Indications For Use: (Specify) of the human body as follows:

Mode of Operazion

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
NeonatalCephalic
Adult Cephalic
Cardiac Adult
CardiacPediatric
Trans-esophageal
Trans-rectal
Trans-vaginal
Intra-luminal		X
Trans-urethral
Peripheralvessel
Laparoscopic

LIULPASE DO NOT GRITTY BELOW THES I T PACE 3 .

William Yis
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Device

K-1

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Prescription Use (Per 21 CFR 801.109)

510(k) Number

{7}------------------------------------------------

510(k) Number (if known):	K971528
Device Name:	SP-701 PL-1926-15 15 MHz Transducer

Fill out one form for each ultrasound system or cransducer.

Diagnostic ultrasound imaging or Doppler analysis Indications For Use: (Specify) of the human body as follows:

Hase of Operacina

Clinical Application	A	B	M	PWD	CWD	Color Doppler	Power (Amplitude) Doppler	Color Velocity Imaging	Combined (Specify)	Other (Specify)
Ophthalmic
Focal
Abdominal
Intra-operative (Specify)
Intra-operative Neurological
Pediatric
Small Organ (Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac Adult
Cardiac Pediatric
Trans-esophageal
Trans-rectal
Trans-vaginal
Intra-luminal		X
Trans-urethral
Peripheral vessel
Laparoscopic

(PLEASE DO MOT WRITT BELOW THE SHIP CO

K-J

William Yin

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic

Radiological Devices
510(k) Number K971528

{8}------------------------------------------------

	510(k) Number (if known) : _	K971528
Device Name :	SP-701	Transducer17 MHzP1-1926-12------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Fill out one form for each ultrasound system or transducer.

Diagnostic ultrasound imaging or Doppler analysis Indications For Use: (Specify) of the human body as follows: Nada of Operation

ClinicalApplication	A	B	M	PWD	CVD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
NeonatalCephalic
Adult Cephalic
Cardiac Adult
CardiacPediatric
Trans-esophageal
Trans-rectal
Trans-vaginal
Intra-luminal		X
Trans-urethral
PeripheralVessel
Laparoscopic

(PLEASE DO NOT VELLE BELLEW THIS LINE CON of CDIE, OLLI

Prescription Use (Per 21 CFR 801.109)

William Y

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic

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510(k) Number K9715

{9}------------------------------------------------

	K971528	510(k) Number if known): -- 2226-20 20 ME Transducer

	Device Name: _________________________________________________________________________________________________________________________________________________________________

Fill our one form for each ultrasound system or cransducer.

Diagnostic ultrasound imaging or Doppler analysis Indications For Use: (Specify) of the human body as follows:

Hads of Operation

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
NeonatalCephalic
Adult Cephalic
Cardiac adult
CardiacPediatric
Trans-esophageal
Trans-rectal
Trans-vaginal
Intra-luminal		X
Trans-urethral
Peripheralvessel
Laparoscopic

PLEASE DO NOT WRITE BELOW THIS LINE - FOR OJP STATISTICAL REVIEW
Commission on Crime, Office of Justice Planning (OJP)

K-1

William

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic

510(k) Number K971528

{10}------------------------------------------------

510(k)	Number	To the days andCARDA	K971528	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Device	Nami	Pan 701	619776-11-1	ransducer1 20 1 200The first and the contract and any and the comments of the county of

Fill our one form for each ultrasound system or transducer.

Diagnostic ultrasound imaging or Doppler analysis Indicacions For Use: (Specify) of the human body as follows: Mode of Operacion

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
NeonatalCephalic
Adult Cephalic
Cardiac Adult
CardiacPediatric
Trans-esophageal
Trans-rectal
Trans-vaginal
Intra-luminal		X
Trans-urethral
Peripheralvessel
Laparoscopic

(PLEASE DO MOT 93779 9972 I THETE T.THE ... PH

William Y

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K971528

K-1

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{11}------------------------------------------------

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10 Ultrasound Device Indications Statement Page 13

	K971528510(k) Number (if known) : ___________________________________________________________________________________________________________________________________________________
	12 MHz Transducer
Device Name:	SP-701 PL-2226-12property and the program and any and the program and the comments ofStatus and American and Comments of

Fill our one form for each ultrasound system or transducer.

Diagnostic ultrasound imaging or Doppler analysis Indications For Use: (Specify) of the human body as follows:

Hode of Operation

ClinicalApplication	A	B	M	PVD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
NeonatalCephalic
Adult Cephalic
Cardiac Adult
CardiacPediatric
Trans-esophageal
Trans-rectal
Trans-vaginal
Intra-luminal		X
Trans-urethral
Peripheralvessel
Laparoscopic

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

Comencenes of Cf, Office of Device Evaluation (CDI)

William

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K971528

Prescription Use (Per 21 CFR 801.109)

x-1

{12}------------------------------------------------

Ultrasound Device Indications Statement Page__________________________________________________________________________________________________________________________________ 13

K971528 510(k) Number (if known): _ SP-701 PL-2220-20 20 MHz Transducer Device Name:_

Fill out one form for each ultrasound system or transducer.

Diagnostic ultrasound imaging or Doppler analysis Indications For Use: (Specify) of the human body as follows:

Hose of Operacion

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
NeonatalCephalic
Adult Cephalic
Cardiac Adult
CardiacPediatric
Trans-esophageal
Trans-rectal
Trans-vaginal
Intra-luminal	X
Trans-urethral
Peripheralvessel
Laparoscopic

SE DO NOT WRITE BELOW THES LINE - Office

K-1

{13}------------------------------------------------

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ 510(k) Number (TE known) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fill out one form for each ultrasound system or transducer.

Indications For Use: Diagnostic ultrasound imaging or Doppler analysis (Specify) of the human body as follows: Node of Operation

ClinicalApplication	A	B	M	PVD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
NeonatalCephalic
Adult Cephalic
Cardiac Adult
CardiacPediatric
Trans-esophageal
Trans-rectal
Trans-vaginal
Intra-luminal	X
Trans-urethral
Peripheralvessel
Laparoscopic
Other Indications or Modes:

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{14}------------------------------------------------

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ 12 MHz Transducer

Fill our one form for each ultrasound system or transducer.

Indications For Use: Diagnostic ultrasound imaging or Doppler analysis (Specify) of the human body as follows: Mode of Operation

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intra-operative(Specify)
Intra-operativeNeurological
Pediatric
Small Organ(Specify)
NeonatalCephalic
Adult Cephalic
Cardiac Adult
CardiacPediatric
Trans-esophageal
Trans-rectal
Trans-vaginal
Intra-luminal	X
Trans-urethral
Peripheralvessel
Laparoscopic

DO NOT US TFP THE THE P

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.