(33 days)
Not Found
No
The device description focuses on the physical components of a catheter and sheath used for sonohysterography, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device facilitates an ultrasound examination by filling the uterus with saline; it does not directly treat a condition or disease.
No
The device facilitates an ultrasound examination of the uterus, but it does not perform the diagnosis itself. Its purpose is to fill the uterus with saline to improve imaging.
No
The device description clearly details physical components (catheter, sheath, luer-lock hub, banding) which are hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "fill the uterus with sterile saline to facilitate the ultrasound examination of the uterus." This describes a procedure performed on the patient's body to aid in imaging, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a catheter and sheath designed for insertion into the uterus. This is a medical device used for a procedure, not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a medical device used for a procedure, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
THE SONOHYSTEROGRAPHY CATHETER (5 Fr) IS INDICATED FOR USE TO FILL THE UTERUS WITH STERILE SALINE TO FACILITATE THE ULTRASOUND EXAMINATION OF THE UTERUS
Product codes (comma separated list FDA assigned to the subject device)
85 LKF
Device Description
The 5F SH catheter consists of two parts: a single lumen catheter and a semi-rigid introducing sheath. The catheter is available in a 5 French diameter with a length of 32 cm. The distal end has a side port. The proximal end is fitted with a female luer-lock hub. The catheter is banded with a non-toxic ink 7 cm from the distal tip The semi-rigid sheath has an internal diameter to allow movement over the catheter and a wall thickness sufficient to provide semi-rigid flexibility. The sheath is 17.5 cm long and flanged and rounded at the distal end to provide a non-traumatic surface to the tissues. The proximal end allows for temporary fixation over the proximal hub of the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians in hospitals
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)
This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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
NOV 1 9 2001
KOI 3437 510(k) Summary As Required by 21 section 807.92 ( c )
- 1-Submitter Name: A & A Medical, Inc.
- 9370 Industrial Trace 2-Address:
- Alpharetta, GA 30004
- (770) 343- 8400 3-Phone:
- (770) 343- 8985 4-Fax:
- Jay Mansour 5-Contact Person:
- 6-Date summary prepared: October 8tt, 2001
7-Device Trade or Proprietary Name: 5F SH Catheter
8-Device Common or usual name: Catheter for Sonohysterography
Cannula, Manipulator/Injector, Uterine 9-Device Classification Name:
10-Substantial Equivalency is claimed against the following device:
- Ultra Catheter Set for Sonohysterography, from Lyco Enterprises, Inc. ●
- 11-Description of the Device:
The device is to be used by physicians in hospitals
The 5F SH catheter consists of two parts: a single lumen catheter and a semi-rigid introducing sheath.
The catheter is available in a 5 French diameter with a length of 32 cm. The distal end has a side port. The proximal end is fitted with a female luer-lock hub. The catheter is banded with a non-toxic ink 7 cm from the distal tip
The semi-rigid sheath has an internal diameter to allow movement over the catheter and a wall thickness sufficient to provide semi-rigid flexibility. The sheath is 17.5 cm long and flanged and rounded at the distal end to provide a non-traumatic surface to the tissues. The proximal end allows for temporary fixation over the proximal hub of the catheter.
12-Intended use of the device:
The SF SH Catheter 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)
1
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 K001115 |
|---|---|
| Attachments inside notification | |
| submission file | REFER TO TABLE ON PAGE 11 OF 12 FOR |
| DETAILS | |
| TECHNOLOGICAL | |
| 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 | |
| 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) |
2
510(k) "SUBSTANTIAL EQUIVALENCE" DECISION-MAKING PROCESS (DETAILED)
Image /page/2/Figure/1 description: This image is a flowchart that outlines the process for determining whether a new device is substantially equivalent to a marketed device. The flowchart starts with comparing the new device to a marketed device and proceeds through a series of questions about the device's intended use, technological characteristics, and potential impact on safety and effectiveness. The flowchart uses a series of yes/no questions to guide the user through the process, ultimately leading to a determination of whether the new device is substantially equivalent or not.
- 510(k) submissions compare new devices to marketed devices. FDA requests additional information in the relationship cen marketed and "predicate" (pe-Amendments or reclassified post-Amendments) devices is unclear. be
· This decision is normally based on descriptive information alone, but limited testing information is somelines required.
*** Data may be in the 310(k), other S10(k)s, the Center's classification files, or the literature.
PAGE 3 of 3
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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles three wavy lines or a caduceus without the staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2001
Jay Mansour, MSQA, BE, LA, RAC Ouality and Regulatory Manager A&A Medical, Inc. 9370 Industrial Trace ALPHARETTA GA 30004
Re: K013437
Trade/Device Name: Sonohysterography Catheter, Model R65-946 Regulation Number: None Regulatory Class: Unclassified Product Code: 85 LKF Dated: October 8, 2001 Received: October 17, 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.
4
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 predicate 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:
| 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
NOV 1 9 2001
Page 1 of 1
| 510(k) Number (if known): | K013437 |
|---|---|
| Device Name: | SONOHYSTEROGRAPHY CATHETER (5 Fr) [R65-946] |
| Indications For Use: |
THE SONOHYSTEROGRAPHY CATHETER (5 Fr) 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)
| (Division Sign-Off) | Nancy Bralon |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K013437 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
|---|---|---|
| --------------------------------------- | ---- | ----------------------------------------------- |
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