(91 days)
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).
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.
The Rejoni Intrauterine Catheter is a sterile, single-lumen uterine catheter intended for delivering contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes. It can also be used for evaluation of tubal patency during HSG.
Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Specific Test / Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Testing | Performance - Mechanical | In accordance with device performance specifications | Pass |
| Performance - Functional | In accordance with device performance specifications | Pass | |
| Dimensional Verification | Met design specifications | Pass | |
| Visual Assessment | Met design specifications | Pass | |
| Tensile Testing (luer to inner shaft; acorn to outer shaft) | Met design specifications | Pass | |
| Kink Testing | Met design specifications | Pass | |
| Leak Testing | Met design specifications | Pass | |
| Biocompatibility | Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxic | Pass |
| Sensitization (ISO 10993-10:2021) | Non-sensitizing | Pass | |
| Intracutaneous Reactivity (ISO 10993-10:2021) | Non-irritating | Pass | |
| Sterility | Sterility Assurance Level (SAL) | 10$^{-6}$ | 10$^{-6}$ (validated) |
| Sterilization Process Validation | Conforms to ISO 11137-1, -2, -3 | Validated | |
| Shelf Life | Device performance over shelf life | Maintains performance as per mechanical testing | Pass |
| Sterile barrier integrity over shelf life | Maintains sterile barrier | Pass | |
| Package integrity after accelerated aging (ASTM 1980-16) | No gross leaks, adequate seal strength, visual integrity | Pass | |
| Package integrity after simulated shipping (ISTA-3A:2018, ASTM D4169-16) | No gross leaks, adequate seal strength, visual integrity | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., how many devices were used for tensile testing, biocompatibility, etc.). However, it indicates these were pre-clinical tests (lab-based) rather than clinical studies with patient data. Therefore, data provenance such as country of origin of data or retrospective/prospective characteristics is not applicable in this context.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The described studies are pre-clinical performance and safety tests (mechanical, biocompatibility, sterility, shelf life) rather than studies that require expert-established ground truth on diagnostic accuracy, for example. The "ground truth" for these tests is defined by established industry standards (ISO, ASTM) and the device's own design specifications.
4. Adjudication Method:
Not applicable. As noted above, these are pre-clinical tests following defined protocols and standards, not studies requiring expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The device is a physical catheter, not an AI-assisted diagnostic tool requiring evaluation of human reader improvement.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
No, a standalone (algorithm only) study was not done. This device is a manual instrument and does not involve an algorithm.
7. Type of Ground Truth Used:
The ground truth for these tests is implicitly or explicitly defined by:
- Design Specifications: For mechanical and functional performance, the device's own engineering and design requirements serve as the ground truth.
- International Standards (ISO, ASTM): For biocompatibility, sterility, and packaging/shelf life, the ground truth is established by the specified ISO and ASTM standards and their acceptance criteria (e.g., non-cytotoxic, SAL of 10$^{-6}$).
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.201 Burlington Road, Suite 210Bedford, MA 01730 |
| Contact Person: | Brian J. Bergeron201 Burlington Road, Suite 210Bedford, MA 01730Telephone: (781) 222-0081 |
| 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
| DeviceAttribute | DeviceName | Predicate Device | Proposed Device | Comparison |
|---|---|---|---|---|
| GoldsteinSonohysterographyCatheter(Legally Marketed:K180300) | Rejoni IntrauterineCatheter(Subject Device:K222798) | |||
| Intended Use | ||||
| Device NameDevice Attribute | Predicate Device | Proposed Device | Comparison | |
| GoldsteinSonohysterographyCatheter(Legally Marketed:K180300) | Rejoni IntrauterineCatheter(Subject Device:K222798) | |||
| Indications for Use | The Margolin HSGCannula is for thedelivery of contrastmedia or saline into theuterine cavity duringHysterosalpingography(HSG) orSonohysterography(SHG) for examinationof the uterus andfallopian tubes.When used for HSG, theMargolin HSG Cannulacan be used forevaluation of tubalpatency.The GoldsteinSonohysterographyCatheter is used to accessthe uterine cavity for thedelivery of saline forSonohysterography(SHG). | The RejoniIntrauterine Catheter isfor the delivery ofcontrast media orsaline into the uterinecavity duringHysterosalpingography(HSG) orSonohysterography(SHG) for examinationof the uterus andfallopian tubes.When used for HSG,the Rejoni IntrauterineCatheter can be usedfor evaluation of tubalpatency.The RejoniIntrauterine Catheter isused to access theuterine cavity for thedelivery of saline forSonohysterography(SHG). | Same | |
| Technology | ||||
| Prescription Only | Yes | Yes | Same | |
| Target Patient | Patient undergoing SHGor HSG procedure | Patient undergoingSHG or HSGprocedure | Same | |
| Anatomical Site | Uterine cavity | Uterine cavity | Same | |
| Method ofIntroduction | Introduced into uterinecavity transcervically | Introduced into uterinecavity | Same | |
| Biocompatibility | Surface device, incontact with mucosaltissue, with limitedcontact (≤ 24h) | Surface device, incontact with mucosaltissue, with limitedcontact (≤ 24h) | Same | |
| DeviceNameDeviceAttribute | Predicate DeviceGoldsteinSonohysterographyCatheter(Legally Marketed:K180300) | Proposed DeviceRejoni IntrauterineCatheter(Subject Device:K222798) | Comparison | |
| Material | Polytetrafluoroethylene,polyethylene,polyurethane, silicone,black ink | Silicone,polycarbonate,Thermoplasticelastomer | Different: Differences indevice materialsbetween the subjectand predicate devicedo not raise differentquestions of safetyand effectiveness(S&E) | |
| Catheter Length | 26 or 36 cm | 24 cm | Similar | |
| Catheter ShaftDistal Diameter | 5.2, 5.3, and 5.4 Fr | 2.2 mm (6.6 F) | Different: The subjectdevice is larger indiameter than thepredicate device. Thisdifference does not raisedifferent questions ofS&E. | |
| Distal TipConfiguration | 3 mm single-sided port,closed end | Open distal tip | Different: Differences inplacement of fluidoutflow openings in thetip of the subject andpredicate device do notraise different questionsof S&E. | |
| Single Use? | Yes | Yes | Same | |
| Sterility | Ethylene Oxide,Sterility Assurance Level(SAL) of 10-6 | Electron BeamSAL of 10-6 | Different: The subjectand predicate device usedifferent sterilizationmethods. This differencedoes not raise differentquestions of safety andeffectiveness. | |
| Shelf Life | 3 years | 12 months | Different: Differentshelf life durations donot raise differentquestions 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, Biologicalevaluation of medical devices- Part 5:Tests for in vitro cytotoxicity | Pass |
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| Test Description | Method | Result |
|---|---|---|
| Sensitization | ISO 10993-10: 2021, Biologicalevaluation of medical devices- Part 10:Tests for irritation and skin sensitization | Pass |
| IntracutaneousReactivity | ISO 10993-10: 2021, Biologicalevaluation of medical devices - Part 10: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.
§ 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.