Rejoni Intrauterine Catheter

K222798 · Rejoni, Inc. · LKF · Dec 16, 2022 · Obstetrics/Gynecology

Device Facts

• Record ID: K222798
• Device Name: Rejoni Intrauterine Catheter
• Applicant: Rejoni, Inc.
• Product Code: LKF · Obstetrics/Gynecology
• Decision Date: Dec 16, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4530
• Device Class: Class 2

Intended Use

The Rejoni Intrauterine Catheter 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 Rejoni Intrauterine Catheter can be used for evaluation of tubal patency. The Rejoni Intrauterine Catheter is used to access the uterine cavity for the delivery of saline for Sonohysterography (SHG).

Device Story

Rejoni Intrauterine Catheter is a sterile, single-lumen catheter for delivering contrast media or saline into the uterine cavity during HSG or SHG procedures. Device features an inner shaft, a support sheath for stiffness, and a repositionable 'acorn' stopper to maintain placement against the external cervical os. A proximal luer lock adapter connects to syringes for fluid delivery. Used in clinical settings by healthcare providers to access the uterine cavity; facilitates visualization of the uterus and fallopian tubes. Benefits include enabling diagnostic imaging of tubal patency and uterine structure.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including mechanical performance (tensile, kink, leak testing), biocompatibility (ISO 10993-5, ISO 10993-10), and sterile barrier integrity testing following accelerated aging and simulated distribution.

Technological Characteristics

Single-lumen catheter; materials include silicone, polycarbonate, and thermoplastic elastomer. Features repositionable acorn stopper and luer lock adapter. Sterilized via Electron Beam (E-Beam) to SAL 10^-6. Validated per ISO 11137 series. Packaging validated per ISO 11607-1/2 and ASTM D4169-16.

Indications for Use

Indicated for patients undergoing Hysterosalpingography (HSG) or Sonohysterography (SHG) procedures for examination of the uterus and fallopian tubes, including evaluation of tubal patency during HSG.

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

• Goldstein Sonohysterography Catheter (K180300)

Reference Devices

• Margolin HSG Cannula

Submission Summary (Full Text)

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December 16, 2022

Rejoni, Inc. Brian J. Bergeron VP Engineering 201 Burlington Road Bedford, MA 01730

Re: K222798

> Trade/Device Name: Rejoni Intrauterine Catheter Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: LKF Dated: September 19, 2022 Received: September 20, 2022

Dear Brian J. Bergeron:

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. Although this letter refers to your product as a device, please be aware 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.

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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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Monica D. Garcia -S

Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K222798

Device Name Rejoni Intrauterine Catheter

Indications for Use (Describe)

The Rejoni Intrauterine Catheter 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 Rejoni Intrauterine Catheter can be used for evaluation of tubal patency.

The Rejoni Intrauterine Catheter is used to access the uterine cavity for the delivery of saline for Sonohysterography (SHG).

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) SUMMARY - K222798

#### GENERAL INFORMATION

| Submission Type: | Traditional 510(k) |
|--------------------|-------------------------------------------------------------------------------------------------------|
| Submitter Name: | Rejoni Inc.<br>201 Burlington Road, Suite 210<br>Bedford, MA 01730 |
| Contact Person: | Brian J. Bergeron<br>201 Burlington Road, Suite 210<br>Bedford, MA 01730<br>Telephone: [phone] |
| Date Prepared: | December 15, 2022 |
| Trade Names: | Rejoni Intrauterine Catheter |
| Common Name: | Intrauterine Catheter |
| Regulation Number: | 21 CFR 884.4530 |
| Regulation Name: | Obstetric-gynecologic specialized manual instrument |
| Regulatory Class: | Class II |
| Product Code: | LKF (Cannula, Manipulator/Injector, Uterine) |

### PREDICATE DEVICE:

Margolin HSG Cannula; Goldstein Sonohysterography Catheter (K180300)

The predicate device has not been subjected to a design-related recall.

### DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Rejoni Intrauterine Catheter is a sterile, single lumen uterine catheter that facilitates access to the uterus to deliver fluids during Hysterosalpingography (HSG) or Sonohysterography (SHG). The Rejoni Intrauterine Catheter consists of an inner shaft and an additional support sheath over the proximal portion of the catheter shaft to provide additional stiffness. A repositionable stopper ("acom") is connected to the support sheath, which is placed on the catheter shaft, and can be repositioned from 0 cm up to 10 cm from the distal tip of the catheter. The stopper maintains placement of the catheter against the external cervical os during the procedure, and a luer lock-style adapter on the proximal end is available for compatibility with syringes. The distal end contains a straight through hole for delivery of fluids during the procedure.

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### INDICATIONS FOR USE

The Rejoni Intrauterine Catheter 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 Rejoni Intrauterine Catheter can be used for evaluation of tubal patency. The Rejoni Intrauterine Catheter is used to access the uterine cavity for the delivery of saline for Sonohysterography (SHG).

# COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS TO THE PREDICATE DEVICE

The intended use and key technological characteristics of the subject and predicate device are compared in the table below

| Device<br>Attribute | Device<br>Name | Predicate Device | Proposed Device | Comparison |
|---------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | | Goldstein<br>Sonohysterography<br>Catheter<br>(Legally Marketed:<br>K180300) | Rejoni Intrauterine<br>Catheter<br>(Subject Device:<br>K222798) | |
| Intended Use | | | | |
| | Device Name<br>Device Attribute | Predicate Device | Proposed Device | Comparison |
| | | Goldstein<br>Sonohysterography<br>Catheter<br>(Legally Marketed:<br>K180300) | Rejoni Intrauterine<br>Catheter<br>(Subject Device:<br>K222798) | |
| Indications for Use | | The Margolin HSG<br>Cannula is for the<br>delivery of contrast<br>media or saline into the<br>uterine cavity during<br>Hysterosalpingography<br>(HSG) or<br>Sonohysterography<br>(SHG) for examination<br>of the uterus and<br>fallopian tubes.<br>When used for HSG, the<br>Margolin HSG Cannula<br>can be used for<br>evaluation of tubal<br>patency.<br>The Goldstein<br>Sonohysterography<br>Catheter is used to access<br>the uterine cavity for the<br>delivery of saline for<br>Sonohysterography<br>(SHG). | The Rejoni<br>Intrauterine Catheter is<br>for the delivery of<br>contrast media or<br>saline into the uterine<br>cavity during<br>Hysterosalpingography<br>(HSG) or<br>Sonohysterography<br>(SHG) for examination<br>of the uterus and<br>fallopian tubes.<br>When used for HSG,<br>the Rejoni Intrauterine<br>Catheter can be used<br>for evaluation of tubal<br>patency.<br>The Rejoni<br>Intrauterine Catheter is<br>used to access the<br>uterine cavity for the<br>delivery of saline for<br>Sonohysterography<br>(SHG). | Same |
| Technology | | | | |
| Prescription Only | | Yes | Yes | Same |
| Target Patient | | Patient undergoing SHG<br>or HSG procedure | Patient undergoing<br>SHG or HSG<br>procedure | Same |
| Anatomical Site | | Uterine cavity | Uterine cavity | Same |
| Method of<br>Introduction | | Introduced into uterine<br>cavity transcervically | Introduced into uterine<br>cavity | Same |
| Biocompatibility | | Surface device, in<br>contact with mucosal<br>tissue, with limited<br>contact (≤ 24h) | Surface device, in<br>contact with mucosal<br>tissue, with limited<br>contact (≤ 24h) | Same |
| Device<br>Name<br>Device<br>Attribute | Predicate Device<br>Goldstein<br>Sonohysterography<br>Catheter<br>(Legally Marketed:<br>K180300) | Proposed Device<br>Rejoni Intrauterine<br>Catheter<br>(Subject Device:<br>K222798) | Comparison | |
| Material | Polytetrafluoroethylene,<br>polyethylene,<br>polyurethane, silicone,<br>black ink | Silicone,<br>polycarbonate,<br>Thermoplastic<br>elastomer | Different: Differences in<br>device materials<br>between the subject<br>and predicate device<br>do not raise different<br>questions of safety<br>and effectiveness<br>(S&E) | |
| Catheter Length | 26 or 36 cm | 24 cm | Similar | |
| Catheter Shaft<br>Distal Diameter | 5.2, 5.3, and 5.4 Fr | 2.2 mm (6.6 F) | Different: The subject<br>device is larger in<br>diameter than the<br>predicate device. This<br>difference does not raise<br>different questions of<br>S&E. | |
| Distal Tip<br>Configuration | 3 mm single-sided port,<br>closed end | Open distal tip | Different: Differences in<br>placement of fluid<br>outflow openings in the<br>tip of the subject and<br>predicate device do not<br>raise different questions<br>of S&E. | |
| Single Use? | Yes | Yes | Same | |
| Sterility | Ethylene Oxide,<br>Sterility Assurance Level<br>(SAL) of 10-6 | Electron Beam<br>SAL of 10-6 | Different: The subject<br>and predicate device use<br>different sterilization<br>methods. This difference<br>does not raise different<br>questions of safety and<br>effectiveness. | |
| Shelf Life | 3 years | 12 months | Different: Different<br>shelf life durations do<br>not raise different<br>questions of S&E. | |

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The indications for use for the subject device and predicate device are identical. Therefore, the intended use is the same (i.e., delivery of contrast medium or saline to the uterine cavity for

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HSG and SHG procedures).

Regarding technological characteristics, the subject and predicate device have different designs and dimensions, material composition, shelf life, and sterilization method. 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 Rejoni Intrauterine Catheter met applicable design and performance requirements. All predetermined acceptance specifications were met in the following tests:

#### Mechanical Testing

The mechanical function and structural integrity of devices were tested to demonstrate that the design specifications from design inputs are fulfilled listed below.

| Test Description | Method | Result |
|--------------------------|------------------------------------------------------|--------|
| Performance - Mechanical | In accordance with device performance specifications | Pass |
| Performance - Functional | In accordance with device performance specifications | Pass |

The following functional and mechanical assessments were performed on the subject device:

- . Dimensional Verification
- Visual Assessment ●
- Tensile Testing (luer to inner shaft; acorn to outer shaft) ●
- Kink Testing ●
- Leak Testing ●

#### Biocompatibility Testing

Per the indications for use, the Rejoni Intrauterine Catheter is categorized as a surface device contacting mucosal membranes for a limited duration (≤ 24 hours). According to the 2020 FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" the following endpoints were tested for the subject device:.

| Test Description | Method | Result |
|------------------|------------------------------------------------------------------------------------------------------------|--------|
| Cytotoxicity | ISO 10993-5: 2009, Biological<br>evaluation of medical devices- Part 5:<br>Tests for in vitro cytotoxicity | Pass |

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| Test Description | Method | Result |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------|--------|
| Sensitization | ISO 10993-10: 2021, Biological<br>evaluation of medical devices- Part 10:<br>Tests for irritation and skin sensitization | Pass |
| Intracutaneous<br>Reactivity | ISO 10993-10: 2021, Biological<br>evaluation of medical devices - Part 10:<br>Tests for irritation and skin sensitization | Pass |

## Sterility

The Rejoni Intrauterine Catheter is sterilized via an Electron Beam (E-Beam) process to a Sterility Assurance Level (SAL) of 10-6. The sterilization process was validated per ISO 11137-1:2006, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices, ISO 11137-2: 2013, Sterilization of health care products – Radiation – Part 2: Establishing the Sterilization Dose, and ISO 11137-3: 2017, Sterilization of health care products – Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control.

# Shelf Life

The Rejoni Intrauterine Catheter has a shelf life of 12-months. Shelf life studies have been conducted to demonstrate that the device maintains its performance (as described in the Mechanical Testing section above) and the packaging will maintain its sterile barrier over the entirety of the intended shelf life. The devices were subjected to environmental conditioning and distribution simulation per ISTA-3A:2018 Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less and ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems. Sterile barrier packaging testing was performed per ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2019, Packaging for Terminally Sterilized Medical Devices -Part 2: Validation requirements for forming, sealing and assembly processes.

Following accelerated aging, per ASTM 1980-16 and simulated shipping distribution, the following package integrity tests were completed:

- Bubble leak test per ASTM F2096, Standard Test Method for Detecting Gross ● Leaks in Packaging by Internal Pressurization (Bubble Test);
- Seal strength per ASTM F88/F88M Standard Test Method for Seal Strength of ● Flexible Barrier Materials: and
- Visual inspection ●

CONCLUSION

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The results of the testing described above demonstrate that the Rejoni Intrauterine Catheter is as safe and effective as the predicate device and supports a determination of substantial equivalence.