Last synced on 30 September 2022 at 11:05 pm

Intrauterine Tamponade Balloon

Page Type
Product Code
Definition
provides temporary control or reduction of postpartum uterine bleeding
Physical State
The device consists of a catheter with a balloon at the distal end. The balloon is distended to achieve tamponade or reduction of post partum uterine bleeding.
Technical Method
The clinician passes the balloon through the vagina and cervix into the uterus. Then, he/she distends the balloon and closely monitors the patient's bleeding.
Target Area
uterus, cervix, vagina
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.4530
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.4530 Obstetric-gynecologic specialized manual instrument

§ 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.

[45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38809, July 25, 2001; 84 FR 71816, Dec. 30, 2019]

Intrauterine Tamponade Balloon

Page Type
Product Code
Definition
provides temporary control or reduction of postpartum uterine bleeding
Physical State
The device consists of a catheter with a balloon at the distal end. The balloon is distended to achieve tamponade or reduction of post partum uterine bleeding.
Technical Method
The clinician passes the balloon through the vagina and cervix into the uterus. Then, he/she distends the balloon and closely monitors the patient's bleeding.
Target Area
uterus, cervix, vagina
Regulation Medical Specialty
Obstetrical and Gynecological
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
884.4530
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 884.4530 Obstetric-gynecologic specialized manual instrument

§ 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.

[45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38809, July 25, 2001; 84 FR 71816, Dec. 30, 2019]