(268 days)
Not Found
No
The description focuses on a mechanical device for circumcision and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used to perform a circumcision, which is a surgical procedure to remove the foreskin, not to treat a disease or condition.
No
Explanation: The device is described as a "circumcision device" used for the "removal of the foreskin/prepuce." It is a surgical tool, not a device used to diagnose a medical condition.
No
The device description explicitly states it consists of two physical components: a transparent plastic bell and a ligature. It also mentions sterilization and packaging testing, which are associated with physical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The wee BELL is a surgical device used to physically remove the foreskin. It is a tool used on the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is to perform a circumcision, which is a surgical procedure.
- Device Description: The description details a physical device (bell and ligature) used for a mechanical process (crushing and removal of tissue).
- Performance Studies: The performance studies focus on the physical and material properties of the device (tensile strength, smoothness, packaging, sterilization, biocompatibility), not on the accuracy or performance of a diagnostic test.
Therefore, the wee BELL falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The wee BELL is a newborn and infant circumcision device. It is used on males with intact foreskin for the purpose of performing a circumcision (removal of the foreskin/prepuce). It consists of two components: wee Bell Circumcision device and ligature. The ligature is intended for use with the wee Bell Circumcision device only.
Product codes (comma separated list FDA assigned to the subject device)
HFX
Device Description
The wee BELL is a newborn and infant circumcision device. It is used on males with intact foreskin for the purpose of performing a circumcision (removal of the foreskin/prepuce). It consists of two components: wee Bell Circumcision device and ligature is intended for use with the wee Bell Circumcision device only. The wee Bell is designed to assist in the performance of a circumferential crushing of the foreskin (prepuce) by tightening the ligature around the bell portion of the device. The remaining foreskin is then removed.
The wee Bell is comprised of two components: a transparent plastic bell and a ligature. It is available in six (6) sizes to accommodate anatomy variation in the size of newborn and infant glands. The device is EtO sterilized and is a single-use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foreskin/prepuce
Indicated Patient Age Range
newborn and infant
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)
Nonclinical functional performance testing was performed on the subject device and included functional testing (visual inspection, tensile testing and smoothness testing), packaging testing per ASTM F88-21, ASTM D4169-22 and ISO 11607, sterilization per ISO 11135:2014 and biocompatibility according to ISO 10993-1 for a surface device in prolonged contact with intact skin. Additionally, material mediated pyrogenicity was conducted.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The FDA logo is in blue.
February 2, 2023
wee MEDICAL % Grace Powers, MS, MBA, RAC Founder/ Principal Consultant Grace Powers - Powers Regulatory Consulting 2451 Cumberland Parkway SE, Suite 3740 Atlanta, GA 30339
Re: K221356
Trade/Device Name: wee BELL Circumcision Device Regulation Number: 21 CFR§ 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: II Product Code: HFX Dated: January 6, 2023 Received: January 6, 2023
Dear Grace Powers:
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.
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/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,
Mark J. Antonino -S
Mark J. Antonino, M.S. 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
2
Indications for Use
510(k) Number (if known) K221356
Device Name wee BELL Circumcision Device
Indications for Use (Describe)
The wee BELL is a newborn and infant circumcision device. It is used on males with intact foreskin for the purpose of performing a circumcision (removal of the foreskin/prepuce). It consists of two components: wee Bell Circumcision device and ligature. The ligature is intended for use with the wee Bell Circumcision device only.
| 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
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the wee BELL Circumcision Device Traditional 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | wee MEDICAL
6804 Baum Drive
Knoxville, TN 37919
Sponsor Contact: D. Preston Smith |
|---------------------|--------------------------------------------------------------------------------------------|
| Submission Contact: | Grace Powers, MS, MBA, RAC |
Grace Powers, MS, MBA, RAC Submission Contact: Founder/Principal Consultant Powers Regulatory Consulting Tel: 404-931-8730
Submission Date: January 25, 2023
Subject Device:
| Trade Name: | wee BELL Circumcision Device |
|---|---|
| Classification Regulation: | 21 CFR §884.4530 |
| Regulation Name: | Obstetric-Gynecologic Specialized Manual Instrument |
| Class: | 2 |
| Common Name: Panel: | Clamp, Circumcision Obstetrics/Gynecology |
| Product Code: | HFX |
Predicate Device: Legally marketed device to which substantial equivalence is claimed: Circumplast circumcision device (K151095)
Device Description
The wee BELL is a newborn and infant circumcision device. It is used on males with intact foreskin for the purpose of performing a circumcision (removal of the foreskin/prepuce). It consists of two components: wee Bell Circumcision device and ligature is intended for use with the wee Bell Circumcision device only. The wee Bell is designed to assist in the performance of a circumferential crushing of the foreskin (prepuce) by tightening the ligature around the bell portion of the device. The remaining foreskin is then removed.
The wee Bell is comprised of two components: a transparent plastic bell and a ligature. It is available in six (6) sizes to accommodate anatomy variation in the size of newborn and infant glands. The device is EtO sterilized and is a single-use device.
4
Figure 1: wee BELL Circumcision Device
Image /page/4/Picture/3 description: The image shows a clear, decorative pull chain for a light fixture or fan. The pull chain is made of clear plastic and has a decorative design. The chain is attached to a white cord that is tied in a knot.
Indications for Use
The wee BELL is a newborn and infant circumcision device. It is used on males with intact foreskin for the purpose of performing a circumcision (removal of the foreskin/prepuce). It consists of two components: wee Bell Circumcision device and ligature is intended for use with the wee Bell Circumcision device only.
Technological Characteristics
The wee BELL Circumcision Device has similar technological characteristics as the predicate device, Circumplast Circumcision Device cleared via K151095. The intended use of the subject and predicate device are the same- the devices are intended to perform circumcisions on infant males.
| Device | Subject Device: | Predicate Device: |
|---|---|---|
| Comparison | wee BELL | Circumplast (K151095) |
| Name | Wee BELL Circumcision Device | Circumplast |
| Manufacturer | Wee MEDICAL, LLC | Novadien Healthcare |
| FDA Product | ||
| Code | HFX, circumcision clamp | HFX, circumcision clamp |
| Regulation | Obstetric- gynecologic specialized manual | |
| instrument | Obstetric- gynecologic specialized | |
| manual instrument | ||
| Intended Use/ | ||
| Indications for | ||
| Use | The wee BELL is a newborn and infant | |
| circumcision device. It is used on males | ||
| with intact foreskin for the purpose of | ||
| performing a circumcision (removal of the | ||
| foreskin/prepuce). It consists of two | ||
| components: wee Bell Circumcision device | ||
| and ligature. The ligature is intended for | ||
| use with the wee Bell Circumcision device | ||
| only. | The Circumplast single use | |
| circumcision device is intended to | ||
| be used to perform circumcisions on | ||
| infant males. This device consists of | ||
| two components: Circumplast | ||
| Circumcision Device and Ligature. | ||
| The Ligature was tested for use with | ||
| Circumplast Circumcision Device | ||
| only. | ||
| Principle of | ||
| Operation | Circumferential crushing of the foreskin | |
| (i.e. crush the foreskin between the inner | ||
| tube and outer clamp) | Circumferential crushing of the | |
| foreskin (i.e. crush the foreskin | ||
| between the inner tube and outer | ||
| clamp) |
5
Traditional 510(k) — wee MEDICAL, LLC wee BELL Circumcision Device
| Device
Comparison | Subject Device:
wee BELL | Predicate Device:
Circumplast (K151095) |
|-----------------------------------------------------|------------------------------|--------------------------------------------|
| Device remains
on the patient
after procedure | Yes, falls off in 3 – 8 days | Yes, falls off in 3 - 7 days |
| | Sizes | 6 sizes (1.0, 1.1, 1.2, 1.3, 1.4, 1.5cm) |
| Materials | Bell: Plastic | Bell: plastic |
| | Ligature: linen | Ligature: linen |
| Device Colorant | No colorant | Unknown |
| Condition of
Use | Single Use | Single Use |
| | Sterilization
Method | EtO |
| Shelf Life | | 18 months |
Performance Data
Nonclinical functional performance testing was performed on the subject device and included functional testing (visual inspection, tensile testing and smoothness testing), packaging testing per ASTM F88-21, ASTM D4169-22 and ISO 11607, sterilization per ISO 11135:2014 and biocompatibility according to ISO 10993-1 for a surface device in prolonged contact with intact skin. Additionally, material mediated pyrogenicity was conducted.
Conclusion
The wee BELL Circumcision Device is substantially equivalent to the legally marketed predicate device as demonstrated by the similar indications for use, similar technologies and performance data, and does not raise different questions of safety and effectiveness.