(28 days)
No
The device description and performance studies indicate a simple mechanical cutter with no mention of AI/ML technologies or related concepts like image processing, training sets, or performance metrics associated with AI/ML.
No
Explanation: A therapeutic device is one that treats or prevents a disease or condition. This device is a cutter used to remove an umbilical cord clamp, which is a procedural step rather than a direct therapeutic intervention.
No
Explanation: The device is described as a cutter designed to cut an umbilical cord clamp, and it does not make contact with the patient. Its function is mechanical, not diagnostic.
No
The device description explicitly states it is a physical cutter composed of plastic and a stainless steel blade, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cut the umbilical cord clamp off a newborn's umbilical cord." This is a mechanical action performed on a medical device (the clamp), not a diagnostic test performed on a biological sample to provide information about a patient's health or condition.
- Device Description: The description clearly states it's a "cutter designed to safely cut the umbilical cord clamp." It's a tool for a physical task.
- No Biological Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide diagnostic information. This device does not interact with or analyze any biological samples.
- No Diagnostic Purpose: The device's function is purely mechanical and does not contribute to diagnosing, monitoring, or treating a disease or condition in a diagnostic sense.
Therefore, this device falls under the category of a surgical or procedural tool, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use is to cut the umbilical cord clamp off a newborn's umbilical cord.
Product codes
85 HFW
Device Description
The subject device is a cutter designed to safely cut the umbilical cord clamp. The device is composed I fier book acrise is a outadiene Styrene) Doc 26720NT Natural resin with a stainless steel blade. The device does not make contact with the patient. The device is provided non-sterile and is labeled for single natient use. The subject device is packaged in a 3"x5" Glassine Bag and will be included in the dispenser box with the Busse Posi-Grip Umbilical Cord Clamps.
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
newborn
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)
Product qualification testing found the umbilical cord clamp cutter to function properly when tested with Busse Posi-Grip Umbilical Cord Clamps. The subject device cut the umbilical cord clamps without problem.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
FDA 510(k) Premarket Notification Busse Umbilical Cord Clamp Cutter
K021055
Pagel
APR 2 9 2002
510 (k) Summary [as required by 21 CFR 807.92]
Date Prepared [21 CFR 807.92(a)(1)]
March 28, 2002
Submitter's Information [21 CFR 807.92(a)(1)]
Joseph M. Azary III C/o Azary Technologies LLC P.O. Box 2156 Huntington, CT. 06484
Azary Technologies has received authorization to submit this 510(k) on behalf of the sponsor Busse Hospital Disposables Inc., 75 Arkay Drive, Hauppauge, NY 11788
Trade Name, Common Name, Classification [21 CFR 807.92(2)(2)]
The device trade names are: Busse Umbilical Cord Clamp Cutter Common Name/Classification Name: Umbilical Cord Clamp Cutter
Predicate Device [21 CFR 807.92(a)(3)]
- Busse Posi-Grip Umbilical Cord Clamp K010835 .
- Precision Dynamics Corporation Umbilical Cord Clamp Cutter K994263 .
- Hollister Umbilical Cord Clamp Cutter K781548 .
Description of the Device [21 CFR 807.92(a)(4)]
The subject device is a cutter designed to safely cut the umbilical cord clamp. The device is composed I fier book acrise is a outadiene Styrene) Doc 26720NT Natural resin with a stainless steel blade. The device does not make contact with the patient. The device is provided non-sterile and is labeled for single natient use. The subject device is packaged in a 3"x5" Glassine Bag and will be included in the dispenser box with the Busse Posi-Grip Umbilical Cord Clamps.
Intended Use [21 CFR 807.92(a)(5)]
The intended use is to cut the umbilical cord clamp off a newborn's umbilical cord.
Technological Characteristics [21 CFR 807.92(a)(6)]
The 510(k) is for the purpose of adding an umbilical cord clamp cutter to the dispenser box of the Busse Posi-Grip Umbilical Cord Clamp (K010835). The Umbilical Cord Clamp is purchased from DeRoyal Industries and is the same umbilical cord clamp cutter sold by Precision Dynamics Corporation (K994263) and is similar in design to the Hollister Umbilical Cord Clamp Cutter (K781548).
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Image /page/1/Picture/0 description: The image shows the text "K021053 page2" in a handwritten style. The text is written in dark ink on a white background. The numbers and letters are clearly legible, and the word "page2" is written below the numbers.
FDA 510(k) Premarket Notification Busse Umbilical Cord Clamp Cutter
Performance Data [21 CFR 807.92(b)(1)]
Product qualification testing found the umbilical cord clamp cutter to function properly when tested with Busse Posi-Grip Umbilical Cord Clamps. The subject device cut the umbilical cord clamps without problem.
Conclusion [21 CFR 807.92(b)(3)]
The subject device is to be added to the dispenser box with Busse Posi-Grip Umbilical Cord Clamps. It is identical to the umbilical cord clamp cutter sold by Precision Dynamics Corporation and is similar in design to the Hollister umbilical cord clamp cutter.
The subject device does not make contact with the patient, is non-sterile and labeled for single patient use. The physician places the jaws over the hinge area of the umbilical cord clamp. Once properly located and engaged, pressure is applied to the cutter grips and the hinge is cut in half.
We conclude that the subject devices are as safe and effective as the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
od and Drug Administratio 00 Corporate Boulevard Rockville MD 20850
APR 2 9 2002
Busse Hospital Disposables, Inc. % Mr. Joseph M. Azary Azary Technologies™, LLC P.O. Box 2156 HUNTINGTON CT 06484
Re: K021055
Trade/Device Name: Busse Umbilical Cord Clamp Cutter Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument
Regulatory Class: II Product Code: 85 HFW Dated: March 28, 2002 Received: April 1, 2002
Dear Mr. Azary:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regard the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de vices marchave boon roomsomed in ausee approval of a premarket approval application (PMA). and Cosmetic Ac. (11ct) that to not requent to the general controls provisions of the Act. The I ou may, therefore, market the Act include requirements for annual registration, listing of general controlly proficions of ractice, 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 your device is classified (500 a00 obs. 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 I lease be deviloed that I brisean. Sat your device complies with other requirements of the Act that I Dr Has Intact a and regulations administered by other Federal agencies. You must or any I oderal buttered to the ext 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 (21 OF ICP art 801), accems (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.
Image /page/2/Picture/12 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
3
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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
FDA 510(k) Premarket Notification Busse Umbilical Cord Clamp Cutter
: 上一篇:
5 10(k) Number (if known): KO2 \ 055
Device Name: Busse Hospital Disposables Inc. Umbilical Cord Clamp Cutter Incline. Dusse rrospital Disposible into interest the unbilical cord clamp off a newbom's umbilical cord.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
Nancy Chrogdon
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K021055 |
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