This document is a 510(k) premarket notification clearance letter from the FDA for the Hudson 2020/2040/2060 Ultrasound Scanners and their corresponding transducers. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

The letter explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already on the market. This is a regulatory pathway for medical devices and does not typically involve the presentation of specific performance studies against acceptance criteria in the same way a de novo or PMA submission might.

Therefore, I cannot extract the requested information about acceptance criteria or a study proving the device meets them from the provided text.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three curved lines.

Public Health Service

DEC 11 2002

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Dr. Martin E. Wendelken Hudson Diagnostic Imaging, LLC 610 Boulevard · ELMWOOD PARK NJ

Re: K022928

Trade Name: Hudson 2020/2040/2060 Ultrasound Scanners Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYO and ITX Dated: November 6, 2002 Received: November 12. 2002

Dear Dr. Wendelken:

We have reviewed your Section 510(k) premarket 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, 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.

This determination of substantial equivalence applies to the following transducers intended for use with the Hudson 2020/2040/2060 Ultrasound Scanners, as described in your premarket notification:

Transducer Model Number

402198 (Hudson 2020/2040 Scanners) 410054 (Hudson 2020/2040 Scanners) 410503 (Hudson 2060 Scanners)

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device

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Page 2 - Dr. Wendelken

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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. 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 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, 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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` .

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Page 3 - Dr. Wendelken

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212. . . . . 11.11 .

Sincerely yours,

David C. Hegpison
for Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Page 1

510(k) Number (if known):

Device Name: Hudson 2020 Ultrasound Scanner

Indications For Use:

High resolution ultrasound imaging of wounds such as:

Clean, closed surgical incisions
Skin graft donor sites
Superficial wounds such as abrasion, skin tears, and blisters
Chafed skin or irritated skin
Ulcers-cavernous and non-cavernous

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ewind C. Eagaton

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number Over-The-Counter Use

4 Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

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Page 2 of 3

510(k) Number (if known): K082998

· Device Name: Hudson 2040 Ultrasound Scanner

Indications For Use:

High resolution ultrasound imaging of wounds such as:

Clean, closed surgical incisions
Skin graft donor sites
Superficial wounds such as abrasion, skin tears, and blisters
Chafed skin or irritated skin
Ulcers—cavernous and non-cavernous

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eavid h. Layson

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 22920 K) Number ver-The-Counter Use

Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

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: Page

510(k) Number (if known): K072928

Device Name: Hudson 2060 Ultrasound Scanner

Indications For Use:

High resolution ultrasound imaging of wounds such as:

Clean, closed surgical incisions
Skin graft donor sites
Superficial wounds such as abrasion, skin tears, and blisters
Chafed skin or irritated skin
Ulcers-cavernous and non-cavernous

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Eygenson

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

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use

(Optional Format 1-2-96)

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Hudson 2020 Ultrasound System

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)Wounds		N

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:_

In conjunction with Wendelken / Pope scanning method and contact media.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Ewind h. Sgrom

(Division Sign-Off) 4
Division of Reproductive, Abdominal,
46 and Radiological Devices
510(k) Number K022928

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Hudson 2040 Ultrasound System

Diagnostic Ultrasound Indications for Use For

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Wounds		N

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

In conjunction with Wendelken / Pope scanning method and contact media.

(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluat (ODE

Gavid G. Ligarson
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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

Hudson 2060 Ultrasound System

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)Wounds		N

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

In conjunction with Wendelken / Pope scanning method and contact media.

(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 Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022928

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

Hudson 2020 # 402198 Transducer 8.0.Mhz Linear Array 40 mm

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)Wounds		N

N= new indication; P= previously deared by FDA; E= added under Appendix E

Additional Comments:_

In conjunction with Wendelken / Pope scanning method and contact media.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CORH, Office of Device Evaluation (ODE)

David A. Bryson

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

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

Hudson 2040 # 402198 Transducer 8.0 Mhz Linear Array 40 mm

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)Wounds		N

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:

In conjunction with Wendelken / Pope scanning method and contact media.

(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Layman

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022978

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

Hudson 2020 - #410054 Transduce 8.0 Mhz Linear Array 60 mm 6.0

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)Wounds		N

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:_

In conjunction with Wendelken / Pope scanning method and contact media.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Dejarm

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022928

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

Hudson 2040 - # 410054 Transducer 8.0 Mhz Linear Array 60 mm 6.0

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
Other (specify)Wounds		N

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:__________________________________________________________________________________________________________________________________________________________

In conjunction with Wendelken / Pope scanning method and contact media.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Lyson

(Division Sign-Off) /
Division of Reproductive, Abdominal,
and Radiological Devices K022928
510(k) Number

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

Hudson 2060 - # 410503 Transducer 10.0 Mhz Linear Array 40 mm 5.0

Diagnostic Ultrasound Indications for Use Form

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletal Superficial
WoundsOther (specify)		N

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:_

In conjunction with Wendelken / Pope scanning method and contact media.

(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Chil A. Dyson

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number 4022928

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.