(161 days)
Exempt
No
The device description focuses on the physical components of a needle set and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
Explanation: This device is used for diagnostic imaging (hysterography and intrauterine venography) to assess chronic pelvic pain/congestion, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section states that the device is "intended for hysterography and intrauterine venography for assessment of chronic pelvic pain/congestion," which directly implies its use in diagnosing a medical condition.
No
The device description clearly outlines physical components (catheter sheath, needle) made of materials like nylon and stainless steel, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "hysterography and intrauterine venography for assessment of chronic pelvic pain/congestion." This describes a procedure performed directly on the patient's body to visualize structures and assess a condition.
- Device Description: The device components (catheter sheath and needle) are designed for direct insertion into the uterus for injecting contrast media.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose diseases or other conditions. This device is used in vivo (within the body) for imaging purposes.
N/A
Intended Use / Indications for Use
The Intrauterine Venogram Needle Set is intended for hysterography and intrauterine venography for assessment of chronic pelvic pain/congestion.
Product codes
85 LKF
Device Description
The Intrauterine Venogram Needle Set contains two components: a catheter sheath and a needle. The single-lumen access catheter has a butb tip, turn connector cap and lock assembly manufactured from nylon. The injection needle is manufactured from stainless steel with a polycarbonate hub. The Information in Venogram Needle set is supplied sterile in lengths from 15 cm to 30 cm and is packaged in a sealed peel-open container.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intrauterine
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Exempt
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
510(k) SUMMARY
Submitted By:
SI
Cindy Rumple Cook OB/GYN 1100 West Morgan Street Spencer, Indiana 47460 (812) 829-4891 April 15, 2004
Device
| Trade Name: | Intrauterine Venogram Needle Set |
|---|---|
| Proposed Classification Name: | Cannula Manipulator/Injector, Uterine |
| Blood, Lancet-Venous System |
Intended Use:
The Intrauterine Venogram Needle Set is intended for hysterography and intrauterine venography for assessment of chronic pelvic pain/congestion
Predicate Devices:
The Intrauterine Venogram Needle Set is similar with respect to indications for use and technology to exist predicate devices in commercial distribution. Specifically, the Intrauterine Venogram Needle Set is similar to the Ott Intrauterine Catheter Set (K891290) manufactured by Cook OB/GYN, and the Echotip Disposable Percutaneous Needle (Exempt) manufactured by Cook OB/GYN.
Device Description:
The Intrauterine Venogram Needle Set contains two components: a catheter sheath and a needle. The single-lumen access catheter has a butb tip, turn connector cap and lock assembly manufactured from nylon. The injection needle is manufactured from stainless steel with a polycarbonate hub. The Information in Venogram Needle set is supplied sterile in lengths from 15 cm to 30 cm and is packaged in a sealed peel-open container.
1
Image /page/1/Picture/2 description: The image shows a close-up of a handwritten note. The writing is in black ink on a white background. The handwriting is somewhat messy and difficult to read, but it appears to say "Kofield" on the top line and "Page" on the bottom line. The note is likely a quick reminder or a signature.
Substantial Equivalence:
The Intrauterine Venogram Needle Set will be manufactured according to specified process controls and a Quality Assurance Program. The device will undergo packaging and sterilization procedures similar to devices currently marketed and distributed by Cook OB/GYN. Being similar with respect to indications for use, materials, and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.
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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines extending from its head, representing the department's mission to promote health and well-being.
Public Health Service
OCT 1 - 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Cindy Rumple Regulatory Affairs Technical Writer Cook Ob/Gyn 1100 W. Morgan Street SPENCER IN 47460
Re: K041062 Trade/Device Name: Intrauterine Venogram Needle Set Regulation Number: None Regulatory Class: Unclassified Product Code: 85 LKF Dated: August 23, 2004 Received: August 24, 2004
,Dear Ms. Rumple:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced w thave and have determined the device is substantially equivalent (for the indications for use stated in above and have detenmentarket predicate devices marketed in interstate commerce prior to the enclosate) to regarly mant date of the Medical Device Amendments, or to devices that have been May 20, 1770, the charactivity 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 do not require approval or a premisions of the Act. The general controls provisions of the Act device, subject to the general 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 (Premarket n your do rise to subject to such additional controls. Existing major regulations affecting your Apple rally, It ifed 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 I lease be advisod that i breation 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 r carrar states and regularing but not limited to registration and listing (21 CFR Part 807); labeling / 1 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (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 Section 510(k) rms lotter withing on. The FDA finding of substantial equivalence of your device to a legally premaince notificate 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:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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
PREMARKET NOTIFICATION
INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K041062 |
|---|---|
| Device Name: | Intrauterine Venogram Needle Set |
| Indications for Use: | The Intrauterine Venogram Needle Set is intended for hysterography and intrauterine venography for assessment of chronic pelvic pain/congestion. |
Prescription Use_ × (Part 21 CFR 801 Subpart D)
OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdo and Radiological Devices 510(k) Number_