(22 days)
Not Found
No
The summary describes a physical catheter set used for delivering contrast media and does not mention any software, image processing, or AI/ML capabilities.
No.
The device is used for the delivery of diagnostic contrast media agents for examination purposes, not for therapeutic intervention or treatment.
No
The device is used for the delivery of diagnostic contrast media agents for examination, not for performing the diagnosis itself. It facilitates the diagnostic process by enabling the imaging modalities (x-rays, ultrasound) to capture images, but it doesn't interpret those images or provide a diagnosis.
No
The device description explicitly states "All components are provided sterile for single use only," indicating physical hardware components are included.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The H/S Catheter Set is used for the delivery of contrast media directly into the female reproductive tract (uterus and fallopian tubes) for imaging purposes (X-rays and ultrasound). This is an in vivo procedure, meaning it is performed within the living body.
- Lack of Sample Analysis: The device itself does not analyze any biological samples. Its function is to facilitate the imaging process by introducing a substance into the body.
Therefore, the H/S Catheter Set falls under the category of a medical device used for diagnostic imaging procedures performed in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The H/S Catheter Set is used for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes.
Product codes (comma separated list FDA assigned to the subject device)
LKF
Device Description
The H/S Catheter Set can be used for conducting either Hysterosalpingography (examination of the uterus and fallopian tubes using x-rays) or Hysterosonography (examination of the uterus and fallopian tubes using ultrasound sonography). All components are provided sterile for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-rays, ultrasound sonography
Anatomical Site
uterus and fallopian tubes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre-clinical testing has been conducted to verify that the product meets the Performance performance requirements described. It was determined that the H/S Data Catheter Set performs safely and effectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
K020951
Page 1 of 2
APR 1 6 2002
Attachment 4
510(k) Summary
| Device
| Description | Trade Name: | H/S Catheter Set | |
|---|---|---|---|
| Common Name: | Hysterosalpingography or Hysterosonography | ||
| Catheter | |||
| Classification Name: Cannula, manipulator/injector, Uterine, Product | |||
| Code LKF | |||
| Predicate | |||
| Device | Modified Hysterosalpingography Set K953034, 8/29/95 | ||
| Date | March 13, 2002 | ||
| Contact | Richard Hettenbach | ||
| Vice President, Regulatory Affairs and Quality Assurance | |||
| Ackrad Laboratories, Inc. | |||
| 70 Jackson Drive | |||
| Cranford, NJ 07016 | |||
| Tel: (908) 276-6390 | |||
| Fax: (908) 276-1895 | |||
| Device | |||
| Description | The H/S Catheter Set can be used for conducting either | ||
| Hysterosalpingography (examination of the uterus and fallopian tubes | |||
| using x-rays) or Hysterosonography (examination of the uterus and | |||
| fallopian tubes using ultrasound sonography). All components are | |||
| provided sterile for single use only. | |||
| Technological | |||
| Characteristics | The H/S Catheter Set has the same technological | ||
| characteristics as the predicate device. The intended use, operating | |||
| principle are identical. The H/S Catheter Set incorporates the same | |||
| product design and is packaged and sterilized using the same materials and | |||
| processes. |
1
K020951
Page 2 of 2
Pre-clinical testing has been conducted to verify that the product meets the Performance performance requirements described. It was determined that the H/S Data Catheter Set performs safely and effectively.
Conclusion
The H/S Catheter Set is substantially equivalent to the predicate Modified Hysterosalpingography Set.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle. The text is in all capital letters and is arranged to follow the curve of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 2002
Mr. Richard Hettenbach Vice President, Regulatory Affairs and Quality Assurance Ackrad Laboratories 70 Jackson Drive CRANFORD NJ 07016
Re: K020951
Trade/Device Name: H/S Catheter Set, (5F) Model61-5005, and (7F) Model 61-5007 Regulation Number: None Regulatory Class: Unclassified Product Code: 85 LKF Dated: March 13, 2002 Received: March 25, 2002
Dear Mr. Hettenbach:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to 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.
3
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 nredicate 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
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
4
Attachment 2
Indications for Use Statement
510(k) Number
Device Name
H/S Catheter Set
Indications for Use
The H/S Catheter Set is used for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes.
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use
David L. Ingram
Sign-Off) le Andominal
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