BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE

K102898 · Panpac Medical Corporation · LKF · Dec 15, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K102898
• Device Name: BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE
• Applicant: Panpac Medical Corporation
• Product Code: LKF · Obstetrics/Gynecology
• Decision Date: Dec 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Indications for Use

The Bellota Sonohysterography Catheter with Cervical Cone (Model: UIC 5FA) is used to access the uterine cavity for saline infusion sonohysterography procedure. The Bellota Sonohysterography Catheter without Cervical Cone (Model: UIC 5F) is used to access the uterine cavity for saline infusion sonohysterography procedure.

Device Story

Bellota Sonohysterography Catheter (Models UIC 5FA and UIC 5F) is a medical device used to access the uterine cavity for saline infusion sonohysterography. The device with cervical cone (UIC 5FA) and without cervical cone (UIC 5F) facilitates the procedure by providing a pathway for saline infusion. It is intended for use by healthcare professionals in a clinical setting. The device is a mechanical instrument; it does not involve electronic processing, software, or automated decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical catheter for uterine access. Models include UIC 5FA (with cervical cone) and UIC 5F (without cervical cone). No electronic, software, or energy-based components.

Indications for Use

Indicated for patients undergoing saline infusion sonohysterography to access the uterine cavity.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/13 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized emblem. The emblem consists of three curved lines that resemble a person with outstretched arms, symbolizing care and protection.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Yen-Ming Pan President PANPAC Medical Corporation 6F-1.2, NO. 202, SEC.3, Tatong Road SHI-CHI-CITY TAIPEI HSIEN 22103 TAIWAN

SEC 1 5 2011

Re: K102898

Trade/Device Name: Bellota Sonohysterography Catheter with Cervical Cone (Model: UIC 5FA) Bellota Sonohysterography Catheter without Cervical Cone

(Model: UIC 5F)

Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LKF Dated: December 1, 2011 Received: December 2, 2011

Dear Mr. Pan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 ihat 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); medical device reporting of medical device-related

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adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

. 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hubert Humphrey

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

## Enclosure

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## Indication for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Panpac Bellota Sonohysterography Catheter

Indications for Use:

The Bellota Sonohysterography Catheter with Cervical Cone (Model: UIC 5FA) is used to access the uterine cavity for saline infusion sonohysterography procedure.

The Bellota Sonohysterography Catheter without Cervical Cone (Model: UIC 5F) is used to access the uterine cavity for saline infusion sonohysterography procedure.

Prescription Use __ X (Per 21 CFR 801 Subpart D)

.

OR

Over-The-Counter Use_ (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH Office of Device Evaluation (ODE)

commission