(14 days)
The H/S Elliptosphere 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.
The H/S Elliptosphere 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.
The provided text describes a 510(k) summary for the H/S Elliptosphere Catheter Set. It asserts that the device is substantially equivalent to a predicate device, but it lacks detailed acceptance criteria and a comprehensive study description that typically accompanies medical device submissions.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria: The document does not explicitly state specific, quantitative acceptance criteria for the device's performance. Instead, it relies on a general statement of meeting performance requirements and being "safe and effective."
Reported Device Performance:
| Performance Aspect | Reported Performance |
|---|---|
| Overall Performance | "Performs safely and effectively." |
| Equivalence | "Substantially equivalent to the predicate Modified Hysterosalpingography Set with Polyurethane Balloon (K961752)." |
Missing Information Regarding the Study that Proves the Device Meets Acceptance Criteria
The provided text does not contain the detailed study information required to answer most of the requested points. The submission is a 510(k) summary, which often focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel clinical study with detailed performance metrics.
Here is an outline of the missing information:
2. Sample size used for the test set and the data provenance:
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not mentioned.
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:
- No MRMC study was mentioned. This device is a catheter set, not an AI-assisted diagnostic tool, so an MRMC study would be irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not mentioned, likely because the performance verification was based on pre-clinical testing for equivalence, not a diagnostic accuracy study.
8. The sample size for the training set:
- Not applicable/Not mentioned. As this is a physical device and not an AI/algorithm, there is no "training set" in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable/Not mentioned. Similar to point 8, this concept does not apply to a physical medical device.
Summary of the Available Information from the Provided Text:
The submission for the H/S Elliptosphere Catheter Set (K013972) is a 510(k) summary. The primary claim for regulatory approval is substantial equivalence to an existing predicate device (Modified Hysterosalpingography Set with Polyurethane Balloon, K961752).
The "study" referenced is "Pre-clinical testing" which aimed to "verify that the product meets the performance requirements described" and determined that it "performs safely and effectively." There are no details beyond this general statement. The 510(k) process often relies on demonstrating that a new device shares the same technological characteristics and intended use as a legally marketed predicate device, thereby inferring safety and effectiveness without requiring extensive new clinical trials with detailed performance metrics like sensitivity, specificity, or reader studies.
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510(k) Summary
| DeviceDescription | Trade Name: | H/S Elliptosphere Catheter Set | |
|---|---|---|---|
| Common Name: | Hysterosalpingography or HysterosonographyCatheter | ||
| Classification Name: | Cannula, manipulator/injector, Uterine, ProductCode LKF | ||
| PredicateDevice | Modified Hysterosalpingography Set with Polyurethane BalloonK961752, 8/19/96 | ||
| Date | November 26, 2001 | ||
| Contact | Richard HettenbachVice President, Regulatory Affairs and Quality AssuranceAckrad Laboratories, Inc.70 Jackson DriveCranford, NJ 07016Tel: (908) 276-6390Fax: (908) 276-1895 | ||
| DeviceDescription | The H/S Elliptosphere Catheter Set can be used for conducting eitherHysterosalpingography (examination of the uterus and fallopian tubesusing x-rays) or Hysterosonography (examination of the uterus andfallopian tubes using ultrasound sonography). All components areprovided sterile for single use only. | ||
| TechnologicalCharacteristics | The H/S Elliptosphere Catheter Set has the same technologicalcharacteristics as the predicate device. The intended use, operatingprinciple are identical. The H/S Elliptosphere Catheter Set incorporates thesame product design and is packaged and sterilized using the samematerials and processes. |
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| Performance Data | Pre-clinical testing has been conducted to verify that the product meets the performance requirements described. It was determined that the H/S Elliptosphere Catheter Set performs safely and effectively. |
|---|---|
| Conclusion | The H/S Elliptosphere Catheter Set is substantially equivalent to the predicate Modified Hysterosalpingography Set with Polyurethane Balloon. |
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and the comments of the comments of the comments of
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and head. 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
DEC 1 7 2001
Mr. Richard Hettenbach Vice President, Regulatory Affairs and Quality Assurance Ackrad Laboratories 70 Jackson Drive P.O. Box 1085 CRANFORD NJ 07016
Re: K013972
Trade/Device Name: H/S Elliptosphere Catheter Set Model 61-4005 Regulation Number: None Regulatory Class: Unclassified Product Code: 85 LKF Dated: November 26, 2001 Received: December 3, 2001
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 for assuration 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.
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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 notification. The I Dri incing of succement of the specification for your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please II you desire specific acvies 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 Additionally, for questions on and process. Also, please note the regulation entitled, "Misbranding Office of Comphanee at (301) 377-1097 (21 CFR Part 807.97). Other general information on by relected to premail.com the Act may be obtained from the Division of Small Manufacturers, your itsponsibilities and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 internet and Goress 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
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Attachment 2
Indications for Use Statement
| 510(k) Number | K 013972 |
|---|---|
| Device Name | H/S Elliptosphere Catheter Set |
| Indications for Use | The H/S Elliptosphere 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 | |
|---|---|---|---|
| ------------------------------------------ | -- | ---- | ---------------------- |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K013972 |
|---|---|
| --------------- | --------- |
510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 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.