HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948

K013491 · A & A Medical, Inc. · LKF · Nov 19, 2001 · Obstetrics/Gynecology

Device Facts

• Record ID: K013491
• Device Name: HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948
• Applicant: A & A Medical, Inc.
• Product Code: LKF · Obstetrics/Gynecology
• Decision Date: Nov 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

The 5F and 7F HSG Catheter set is a device used to fill the uterus with sterile saline to facilitate the ultrasound examination of the uterus

Device Story

HSG Catheter Set (5F and 7F) is a physician-operated device used in hospital settings for hysterosalpingography. The device consists of a double-lumen catheter and a semi-rigid introducing sheath. The catheter features a distal non-latex Kraton balloon (1.5 cc capacity for 5F; 3 cc for 7F) and a side port. The proximal end includes a halkey clamp, female luer lock hub, one-way stopcock, and a 3cc syringe. The device is inserted to fill the uterus with sterile saline, providing contrast for ultrasound imaging. This allows physicians to visualize the uterine cavity, aiding in clinical diagnosis and decision-making regarding uterine health.

Clinical Evidence

No clinical data provided; substantial equivalence is based on descriptive information and comparison of technological characteristics.

Technological Characteristics

Double-lumen catheter and semi-rigid introducing sheath; 5F and 7F diameters; 30 cm length; non-latex Kraton balloon; female luer lock hub; one-way stopcock; 3cc syringe. Sterilization via Ethylene Oxide.

Indications for Use

Indicated for filling the uterus with sterile saline to facilitate ultrasound examination of the uterus in patients undergoing such procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• HSG Catheter Set for Hysterosalpingography (Lyco Enterprises, Inc.)

Submission Summary (Full Text)

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### 510(k) Summary NOV 1 9 2001 As Required by 21 section 807.92 ( c )

- 1-Submitter Name: A & A Medical, Inc.
- 2-Address: 9370 Industrial Trace
- Alpharetta, GA 30004 3-Phone:
- (770) 343- 8400 4-Fax: [phone]
- Jay Mansour 5-Contact Person:
- 6-Date summary prepared: October 17th, 2001
- 7-Device Trade or Proprietary Name: HSG Catheter Set (5F and 7F)
- 8-Device Common or usual name: Catheter for Hysterosalpingography
- 9-Device Classification Name: Cannula, Manipulator/Injector. Uterine
- 10-Substantial Equivalency is claimed against the following device:
- . HSG Catheter Set for Hysterosalpingography, from Lyco Enterprises. Inc.
- 11-Description of the Device:
- The device is to be used by physicians in hospitals

The HSG catheter set consists of two parts: a double lumen catheter and a semi-rigid introducing sheath.

The catheter is available in two different sizes 5 and 7 French diameter with a length of 30 cm. The distal end has a side port and a non-latex Kraton balloon whose capacity is 1.5 cc for 5F and 3cc for 7F.

The proximal end that ends in side port is fitted with a halkey clamp and female luer lock hub. The other channel is fitted with one way stop cock and a 3cc syringe.

#### 12-Intended use of the device:

The 5F and 7F HSG Catheter set is a device used to fill the uterus with sterile saline to facilitate the ultrasound examination of the uterus

#### 13-Safety and Effectiveness of the device:

This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)

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## 14-Summary comparing technological characteristics with other predicate device:

Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached.

| FDA file reference number | 510k K943494 |
|-----------------------------------------------------|------------------------------------------------|
| Attachments inside notification<br>submission file | REFER TO TABLE ON PAGE 11 OF 12 FOR<br>DETAILS |
| TECHNOLOGICAL<br>CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Identical |
| Materials | Identical |
| Performance | Identical |
| Sterility | Similar (Ethylene Oxide instead of Gamma) |
| Biocompatibility | Identical |
| Mechanical safety | Identical |
| Chemical safety | Identical |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical |
| Compatibility with environment<br>and other devices | Identical |
| Where used | Identical |
| Standards met | Identical |
| Electrical safety | Identical (not applicable) |
| Thermal safety | Identical (not applicable) |
| Radiation safety | Identical (not applicable) |

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510(k) "SUBSTANTIAL EQUIVALENCE" DECISION-MAKING PROCESS (DITAILED)

Image /page/2/Figure/2 description: This image is a flowchart that outlines the process for determining if a new device is substantially equivalent to a marketed device. The flowchart starts with the question, "New Device is Compared to Marketed Device" and proceeds through a series of questions about the device's intended use, technological characteristics, and performance data. The flowchart ends with a determination of whether the new device is "Substantially Equivalent" or "Not Substantially Equivalent".

SIO(k) submissions compare new devices to marketed devices. FDA requests additional inforclarions in the relations big between marketed and "predicate" (pre-Amendments or reclassified post-Amendments) devices is unders.

· This decision is normally based on descriptive information alone, but limited testing information is sometimes required.

*** Data may be in the 310(k), other S10(k)s, the Center's classification files, or the linerature.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The overall design is simple and conveys a sense of official government affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 9 2001

Mr. Jay Mansour, MSQA, BE, LA, RAC Quality and Regulatory Manager A & A Medical, Inc. 9370 Industrial Trace ALPHARETTA GA 30004

Re: K013491

Trade/Device Name: HSG Catheter Set (5F and7F) Model R65-947 and R65-948 Regulation Number: None Regulatory Class: Unclassified Product Code: 85 LKF Dated: October 17, 2001 Received: October 22, 2001

Dear Mr. Mansour:

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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket I ills letter will anow you to ocgin nationing your device of your device to a legally marketed noutication. The I Dri- inding of succiantial 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 IT you desire specific advice for your de of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, 101 questions on the premes . Also, please note the regulation entitled, "Misbranding Other of Comphanes at (2017 077 100 (21 CFR Part 807.97). Other general information on by relefence to promation of the Act may be obtained from the Division of Small Manufacturers, your lesponsibilities under the rice may of its toll-free number [phone] or [phone] niccilational and Oolisamer : Itsitive.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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NOV 1 9 2001

of Page

510(k) Number (if known): ___K013491

Device Name: HSG Catheter Set (5F & 7F)

Indications For Use:

HSG Catheter Set (5F & 7F) is indicated for use to fill the uterus with sterile saline to facilitate the ultrasound examination of the uterus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use v (Per 21 CFR 801.109) Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 3-10-98)

Ylancy C. Cropton

(Division Sten-Off)
Division of aoducthminal.
and Rediefental Devic
510kl N
K013491