(313 days)
Not Found
No
The device description mentions an electronic clock for time recording, but there is no indication of AI or ML being used for analysis, decision-making, or any other function.
No.
The device's intended use is to clamp and cut the umbilical cord, which is a procedural/surgical tool, not a device directly involved in treating a disease or disorder.
No
The device is described as an umbilical cord clamp and cutter, which is a surgical tool for performing a physical action (clamping and cutting), not for diagnosing a condition or disease.
No
The device description explicitly states it is a molded plastic device and includes an electronic clock, indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- Device Function: The "Regular and Special Umbilical Cord Clamp and Cutter" is a surgical instrument used to physically clamp and cut the umbilical cord. It performs a physical action on the body, not a diagnostic test on a sample.
- Intended Use: The intended use is clearly stated as "simultaneously clamping and cutting the umbilical cord of the new born baby at delivery." This is a procedural use, not a diagnostic one.
The device is a surgical tool, not a diagnostic test.
N/A
Intended Use / Indications for Use
Regular and Special Umbilical Cord Clamp and Cutter are intended for use in simultaneously clamping and cutting the umbilical cord of the new born baby at delivery
Product codes (comma separated list FDA assigned to the subject device)
NBZ
Device Description
"Regular and Special Umbilical Cord Clamp and Cutter" manufactured by "Ningbo Feite Medical Device Co., Ltd." are a single use, disposable, molded plastic device, unit packaged and sterile, intended to use for the simultaneously cut and clamp umbilical cord of the new born baby at delivery.
"Special Umbilical Cord Clamp and Cutter" are comprised of the exact same part as "Regular Umbilical Cord Clamp and Cutter", with the addition of an electronic clock. The time is automatically recorded when the cutting is performed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Umbilical cord
Indicated Patient Age Range
new born baby
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)
Bench testing was performed to ensure that the "Regular and Special Umbilical Cord Clamp and Cutter" met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing demonstrated that the devices are biocompatible.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 28, 2016
Ningbo Feite Medical Device Co., Ltd % Charles Shen Official Correspondent Manton Business and Technology Services 37 Winding Ridge Oakland, NJ 07436
Re: K152350
Trade/Device Name: Regular and Special Umbilical Cord Clamp and Cutter Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: Class II Product Code: NBZ Dated: Mav 27, 2016 Received: May 27, 2016
Dear Charles Shen,
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. 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. 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 (reporting of medical device
1
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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) K152350
Device Name
Regular and Special Umbilical Cord Clamp and Cutter
Indications for Use (Describe)
Regular and Special Umbilical Cord Clamp and Cutter are intended for use in simultaneously clamping and cutting the umbilical cord of the new born baby at delivery
Type of Use (Select one or both, as applicable)
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:
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
Submitter & Foreign Manufacture Identification 5.1
Ningbo Feite Medical Device Co., Ltd. Tongpenzha, Zhonggongmiao Street, Yinzhou District, 315192, Ningbo, Zhejiang Province, China
5.2 Contact Person
Charles Shen Manton Business and Technology Services 37 Winding Ridge, Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com
5.3 Date of Summary: July 29, 2014
| 5.4 Device Name: | |
|---|---|
| Proprietary Name: | Regular and Special Umbilical Cord Clamp and Cutter |
| Common Name: | Clamp and Cutter, Umbilical |
| Classification Name: | Clamp and Cutter, Umbilical |
| Device Classification: | II |
| Regulation Number: | 21 CFR 884.4530 |
| Panel: General | Obstetrics/Gynecology |
| Product Code: | NBZ |
ર્સ્ડ Predicate Device Information:
- K011621, "Koala Clamp and Cutter", manufactured by "Maternus Inc." in San (1) Antonio, TX.
5.6 Device Description:
"Regular and Special Umbilical Cord Clamp and Cutter" manufactured by "Ningbo Feite Medical Device Co., Ltd." are a single use, disposable, molded plastic device, unit packaged and sterile, intended to use for the simultaneously cut and clamp umbilical cord of the new born baby at delivery.
"Special Umbilical Cord Clamp and Cutter" are comprised of the exact same part as "Regular Umbilical Cord Clamp and Cutter", with the addition of an electronic clock. The time is automatically recorded when the cutting is performed.
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5.7 Intended Use:
Regular and Special Umbilical Cord Clamp and Cutter are intended for use in simultaneously clamping and cutting the umbilical cord of the new born baby at delivery
Technological Comparison with Predicate Device 5.8
The following table shows similarities and differences of use, design, and material between our device and the predicate devices.
| Table 5.1: Comparison of Intended Use, Design, Material, and Processing | |||
|---|---|---|---|
| Description | Subject Device | Predicate Device (K011621) |
|---|---|---|
| Indication for | ||
| Use | Regular and Special Umbilical Cord | |
| Clamp and Cutter are intended for use | ||
| in simultaneously clamping and | ||
| cutting the umbilical cord of the new | ||
| born baby at delivery | The indications for Use of the Koala | |
| Clamp & Cutter are to simultaneously | ||
| cut and clamp umbilical cord. | ||
| Target | ||
| Population | All vaginal births | All vaginal births |
| Basic Design | Combine clamp and cutter in the same | |
| unit | Combine clamp and cutter in the same | |
| unit | ||
| Clamp Material | Plastic | Plastic |
| Cutter Material | Stainless steel | Stainless steel |
| Dimension | Clamp @ baby side: Arm 1: 37.20 mm; | |
| Arm 2: 38.05 mm | ||
| Clamp @ placenta side: Arm 1: 34.70 | ||
| mm, Arm 2: 36.07 mm | ||
| Blade: 44 x 16 mm | 74 x 50.6 x 32.9 mm | |
| Single Use | Yes | Yes |
| Biocompatible | Yes | Yes |
| Sterile | Sterilization with EO | Sterilization with EO |
| Anatomical Site | Umbilical cord | Umbilical cord |
| Other feature | Special Umbilical Cord Clamp and | |
| Cutter has clock function | No |
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Our device is essentially identical to the predicate device in terms of indications for use, design, material, and processing between our device and the predicate devices. Minor differences do not impact the safety and effectiveness of the device.
5.9 Summary of Device Testing:
Bench testing was performed to ensure that the "Regular and Special Umbilical Cord Clamp and Cutter" met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing demonstrated that the devices are biocompatible.
5.10 Conclusion
The "Regular and Special Umbilical Cord Clamp and Cutter" are substantially equivalent to the predicate device.