(266 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and function of a catheter for delivering fluid, with no mention of AI or ML.
No.
The device descriptions and intended uses indicate it is for delivering contrast media or saline for diagnostic procedures (Hysterosalpingography and Sonohysterography), not for treating a disease or condition.
Yes
The document states that the devices are used during "diagnostic procedures" or for "examination" and "evaluation" of anatomical sites.
No
The device description clearly describes physical catheters with a silicone "acom" wedge, indicating a hardware device, 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 for the delivery of contrast media or saline into the uterine cavity for diagnostic imaging procedures (HSG and SHG). These procedures involve imaging the internal structures of the body.
- Device Description: The device is a catheter designed to facilitate the delivery of fluid into the uterus. It's a physical instrument used within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not perform such tests on samples.
The device is a medical device used in conjunction with imaging modalities to aid in diagnosis, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The Margolin HSG Cannula is for the delivery of contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes. When used for HSG, the Margolin HSG Cannula can be used for evaluation of tubal patency.
The Goldstein Sonohysterography Catheter is used to access the uterine cavity for the delivery of saline for Sonohysterography (SHG).
Product codes (comma separated list FDA assigned to the subject device)
LKF
Device Description
The Margolin HSG Cannula and Goldstein Sonohysterography Catheter are single lumen uterine catheters that facilitate access to the uterus to deliver fluid (contrast media or saline) during diagnostic procedures. Both feature a silicone "acom" wedge that seals the cervical canal and maintains the position of the catheter during the procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterine cavity, uterus, fallopian tubes, cervical canal, external cervical os.
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)
The following tests were performed to demonstrate that the Margolin HSG Cannula and Goldstein Sonohysterography Catheter met applicable design and performance requirements. All predetermined acceptance specifications were met in the following tests:
- Sterilization Validation testing per ISO 11135-1:2007
- Transportation Simulation study per ASTM D4169-16
- Package Integrity testing after aging to three years:
- Bubble Leak test per ASTM F2096-11
- Seal Strength testing per ASTM F88-09
- Visual Inspection per ASTM F1866-09
- Biocompatibility studies, as follows:
- Cytotoxicity per ISO 10993-5:2009
- Sensitization per ISO 10993-10:2010
- Irritation per ISO 10993-10:2010
- Performance studies before and after aging to three years. The testing below was conducted on the Margolin HSG Cannula and the Goldstein Sonohysterography Catheter unless stated otherwise:
- Dimensional Verification: Testing verified that the catheter, stylet, ink marker bands and silicone positioner dimensions are in conformance with Cook's predetermined acceptance specifications.
- Lumen Patency and Liquid Leakage Test: Testing demonstrated that the fluid path of the catheter was patent and did not leak from any joints parts when tested with a predetermined injection pressure.
- Tensile Testing (hub to shaft [both devices], hub to stylet wire [Margolin HSG Cannula], and tip to shaft [Margolin HSG Cannula]): Testing demonstrated that that the peak load value was greater than the predetermined acceptance specification.
- Positioner Force to Displace: Testing was conducted to assess the force needed to displace the movable silicone positioner of the Goldstein Sonohysterography Catheter. In conformance to Cook requirements, the predetermined acceptance specification was met.
- Stylet Compatibility Testing was conducted to demonstrate that the stylet is compatible with the Margolin HSG Cannula (i.e., fits within the catheter lumen and does not extend beyond the tip of the catheter). In conformance to Cook requirements, the predetermined acceptance specification was met.
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
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October 26, 2018
Cook Incorporated Naomi Funkhouser Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402
Re: K180300
Trade/Device Name: Margolin HSG Cannula, Goldstein Sonohysterography Catheter Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: LKF Dated: September 26, 2018 Received: September 27, 2018
Dear Naomi Funkhouser:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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.
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sharon M. Andrews -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180300
Device Name Margolin HSG Cannula Goldstein Sonohysterography Catheter
Indications for Use (Describe)
The Margolin HSG Cannula is for the delivery of contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes. When used for HSG, the Margolin HSG Cannula can be used for evaluation of tubal patency.
The Goldstein Sonohysterography Catheter is used to access the uterine cavity for the delivery of saline for Sonohysterography (SHG).
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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COOK INCORPORATED Page 1 of 5 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. 12.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
510(k) SUMMARY
Margolin HSG Cannula Goldstein Sonohysterography Catheter Date Prepared: October 26, 2018
Submitted By:
| Applicant: | Cook Incorporated |
|---|---|
| Contact: | Naomi Funkhouser, Rohini Patel |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone Number: | (812) 335-3575 x10-4371 |
| Contact Fax Number: | (812) 332-0281 |
Device Information:
| Trade Name: | Margolin HSG Cannula
Goldstein Sonohysterography Catheter |
|------------------------------|--------------------------------------------------------------|
| Common Name: | HSG, SHG Catheters |
| Regulation Number: | 21 CFR §884.4530 |
| Regulation Name: | Obstetric-gynecologic specialized manual instrument |
| Classification Product Code: | LKF – Cannula, Manipulator/Injector, Uterine |
| Device Classification: | Class II |
Predicate Devices:
K083594 - Foam Seal Catheter from OBG Products
The predicate device has not been subjected to a design-related recall.
Device Description:
The Margolin HSG Cannula and Goldstein Sonohysterography Catheter are single lumen uterine catheters that facilitate access to the uterus to deliver fluid (contrast media or saline) during diagnostic procedures. Both feature a silicone "acom" wedge that seals the cervical canal and maintains the position of the catheter during the procedure.
4
Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, block letters in the upper portion of the logo. Below that, the word "MEDICAL" is written in smaller, white block letters.
BLOOMINGTON, IN 47402-0489 U.S.A 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
Margolin HSG Cannula
The Margolin HSG Cannula is comprised of a cannula and stylet. The cannula is made of polyurethane with a stationary silicone wedge at the distal end that maintains the position of the catheter in the external cervical os and 9.0 French tip which is approximately 2 cm in length. The wedge, characterized by an acorn shape features two 180° opposed sideports. The proximal end of the cannula is designed with a female luer lock-style adaptor. The Margolin HSG Cannula is provided with a stainless-steel stylet. The stylet is designed with a female luer lock-style plug proximal fitting. The Margolin HSG Cannula is 25 cm in length, is supplied sterile (ethylene oxide), and intended for one-time use.
Goldstein Sonohysterography Catheter
The Goldstein Sonohysterography Catheter includes four versions that range in size from 5.2 to 5.4 French. The 5.2 French catheters are made of polytetrafluoroethylene tubing and the 5.3 and 5.4 French catheters are made of polyethylene tubing. The 5.4 French catheter is designed with an additional polyurethane support sheath over the proximal portion of the catheter shaft to provide additional stiffness. A repositionable silicone acorn wedge is placed on the catheter shaft proximal to an ink band that is 7 cm from the distal tip of the catheter. The silicone acorn maintains placement of the catheter against the external cervical os, and a luer lock-style adapter is available for compatibility with luer lock syringes. The Goldstein Sonohysterography Catheter is 26 to 36 cm in length, supplied sterile (ethylene oxide), and intended for one-time use. Additional information on the different device versions is provided below:
- J-GSHC-522620 5.2 French and 26 cm long .
- J-GSHC-523620 5.2 French and 36 cm long .
- J-GSHC-532600 5.3 French and 26 cm long .
- J-GSHC-542600-SV 5.4 French and 26 cm long .
Indications for Use:
- The Margolin HSG Cannula is for the delivery of contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes. When used for HSG, the Margolin HSG Cannula can be used for evaluation of tubal patency.
- The Goldstein Sonohysterography Catheter is used to access the uterine cavity for the . delivery of saline for Sonohysterography (SHG).
5
Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, bold, sans-serif font, with a registered trademark symbol next to it. Below "COOK", the word "MEDICAL" is also in white, bold, sans-serif font, but smaller in size.
K 180300 COOK INCORPORATED Page 3 of 5 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
Comparison to Predicate Device:
The following table compares the Margolin HSG Cannula and Goldstein Sonohysterography Catheter to the predicate device:
| Device
Characteristics | Subject Device
(K180300)
Margolin | Subject Device
(K180300)
Goldstein | K083594 - The
Foam Seal
SIS/HSG
Catheter | Comparison |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The Margolin HSG
Cannula is for the
delivery of contrast
media or saline into the
uterine cavity during
Hysterosalpingography
(HSG) or
Sonohysterography
(SHG) for examination
of the uterus and
fallopian tubes. When
used for HSG, the
Margolin HSG
Cannula can be used
for evaluation of tubal
patency. | The Goldstein
Sonohysterography
Catheter is used to
access the uterine
cavity for the
delivery of saline
for
Sonohysterography
(SHG). | The Foam Seal
SIS/HSG Catheter is
intended for
introduction of liquid
into the uterine cavity
for ultrasonogram and
radiology procedure
of the uterus and
fallopian tubes. | Same intended use:
Both devices are
intended for use in
delivery of contrast
medium or saline to
the uterine cavity for
HSG and SHG
procedures |
| Catheter Material | Polyurethane | Polyethylene or
Teflon | Unspecified plastic | Different: The
catheter material is
not known for the
predicate device.
Differences in
device materials
between the subject
and predicate device
do not raise different
questions of safety
and effectiveness
(S&E). |
| Positioner/Cervical
Seal | Yes | Yes | Yes | Same |
| Positioner/Cervical
Seal Material | Silicone | Silicone | Unspecified Foam | Different: The
positioner/seal
material is not
known for the
predicate device.
Differences in
device materials
between the subject
and predicate device
do not raise different
questions of S&E. |
| Catheter Length | 25 cm | 26 cm to 36 cm | 37 cm | Different: The
subject devices are
shorter than the
predicate device. |
| | | | | This difference does
not raise different
questions of S&E. |
| Tip Size | 8.76 Fr | 5.2 Fr to 5.4 Fr | 1.6mm to 3 mm
(4.8 Fr to 9.0 Fr) | Different: Tip sizes
are different
between the subject
and predicate
devices. These
differences do not
raise different
questions of S&E. |
| Distal Tip
Configuration | 19-guage dual oval
side ports, closed
ended. | 3 mm single side
port, closed ended | open ended | Different:
Differences in
placement of fluid
outflow openings in
the tip of the subject
and predicate
devices do not raise
different questions
of S&E. |
6
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COOK INCORPORATED Page 4 of 5 BLOOMINGTON, IN 47402-0489 U.S.A 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
As shown above, the indication for use of the subject devices, Margolin HSG Cannula and the Goldstein Sonohysterography Catheter, as compared to the predicate device, the Foam Seal Catheter (K083594), is not identical; however, the differences do not alter the intended use of the devices, which are the same (i.e., delivery of contrast medium or saline to the uterine cavity for HSG and SHG procedures).
Regarding technological characteristics, the subject and predicate devices are similar in general design. However, differences do exist as described in the table above (e.g., dimensions, materials, tip configuration, etc.). The differences identified do not raise different questions of safety and effectiveness as compared to the predicate device as stated in the table.
Performance Data:
The following tests were performed to demonstrate that the Margolin HSG Cannula and Goldstein Sonohysterography Catheter met applicable design and performance requirements. All predetermined acceptance specifications were met in the following tests:
- . Sterilization Validation testing per ISO 11135-1:2007
- Transportation Simulation study per ASTM D4169-16 ●
- Package Integrity testing after aging to three years:
- o Bubble Leak test per ASTM F2096-11
- Seal Strength testing per ASTM F88-09 o
- Visual Inspection per ASTM F1866-09 O
7
Image /page/7/Picture/1 description: The image shows the logo for Cook Medical. The logo is a red rectangle with the word "COOK" in white, sans-serif font on the top half. There is a registered trademark symbol to the right of the word "COOK". The bottom half of the logo is a smaller red rectangle with the word "MEDICAL" in white, sans-serif font.
- Biocompatibility studies, as follows:
- o Cytotoxicity per ISO 10993-5:2009
- Sensitization per ISO 10993-10:2010 o
- 0 Irritation per ISO 10993-10:2010
- . Performance studies before and after aging to three years. The testing below was conducted on the Margolin HSG Cannula and the Goldstein Sonohysterography Catheter unless stated otherwise:
- o Dimensional Verification: Testing verified that the catheter, stylet, ink marker bands and silicone positioner dimensions are in conformance with Cook's predetermined acceptance specifications.
- o Lumen Patency and Liquid Leakage Test: Testing demonstrated that the fluid path of the catheter was patent and did not leak from any joints parts when tested with a predetermined injection pressure.
- Tensile Testing (hub to shaft [both devices], hub to stylet wire [Margolin o HSG Cannula], and tip to shaft [Margolin HSG Cannula]): Testing demonstrated that that the peak load value was greater than the predetermined acceptance specification.
- o Positioner Force to Displace: Testing was conducted to assess the force needed to displace the movable silicone positioner of the Goldstein Sonohysterography Catheter. In conformance to Cook requirements, the predetermined acceptance specification was met.
- Stylet Compatibility Testing was conducted to demonstrate that the stylet is o compatible with the Margolin HSG Cannula (i.e., fits within the catheter lumen and does not extend beyond the tip of the catheter). In conformance to Cook requirements, the predetermined acceptance specification was met.
Conclusion:
The results of the performance testing described above demonstrates that the subject devices Margolin HSG Cannula and the Goldstein Sonohysterography Catheter are as safe and effective as the predicate device and supports a determination of substantial equivalence.