(245 days)
Kilejian Circumcisor, Gomco Circumcision Clamp, Mogan Circumcision Clamp, and Hollister Plastibell
Not Found
No
The summary describes a mechanical device for circumcision and does not mention any AI or ML components or functionalities.
No
The device is described as a tool for circumcision, which is a surgical procedure, not a therapeutic treatment for a disease or condition.
No
The device description indicates it is used for the surgical procedure of circumcision, which is a treatment, not a diagnostic process.
No
The device description clearly states it is composed of physical components (plastic conic tube, plastic clamping mechanism) and is sold as a sterile, single-use device with a sizing guide. This indicates it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Smart Klamp® is a surgical device used for the physical removal of the foreskin. It does not analyze any biological specimens.
- Intended Use: The intended use clearly describes a surgical procedure (circumcision), not a diagnostic test performed on a sample.
The device description and intended use align with a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
The Device is indicated for Circumcision of newborns and older males, defined as circumferential excision of the foreskin or prepuce at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.
Product codes
85 HFX
Device Description
The Smart Klarap® is a device composed of two components; a transparent plastic conic tube, and a plastic white clamping mechanism. The device is sold sterile for single use, packaged with a disposable sizing guide in a sterile pouch. The Smart Klamp® is available in multiple sizes, to accommodate newborn to adult patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foreskin or prepuce (penis)
Indicated Patient Age Range
newborns and older males
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Kilejian Circumcisor, Gomco Circumcision Clamp, Mogan Circumcision Clamp, and Hollister Plastibell
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
MAR - 8 2004
|K03209|
510(K) SUMMARY
Date: 19 June 2003
Submission Correspondent: Emergo Group, Inc.
Address: 1684 East Gude Drive, Suite 202 Rockville, MD 20850
(301) 762-2828 Phone: Fax: (301) 762-4043
Contact: Mr. Rene van de Zande
| Trade Name: | Smart Klamp® |
|---|---|
| Common Name: | Clamp, Circumcision |
| Classification: | Obstetric-Gynecologic Specialized Manual Instrument |
Description: The Smart Klarap® is a device composed of two components; a transparent plastic conic tube, and a plastic white clamping mechanism. The device is sold sterile for single use, packaged with a disposable sizing guide in a sterile pouch. The Smart Klamp® is available in multiple sizes, to accommodate newborn to adult patients.
Intended Use: The Device is indicated for Circumcision of newborns and older males, defined as circumferential excision of the foreskin or prepuce at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.
Predicate Devices: The predicate devices referenced in this submission are: the Kilejian Circumcisor, Gomco Circumcision Clamp, Mogan Circumcision Clamp, and Hollister Plastibell.
Summary and Conclusions Regarding Substantial Equivalence:
By definition, a device is substantially equivalent when the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.
The differences between the Smart Klamp® and the predicate devices cited do not raise any different questions regarding safety and effectiveness. The differences in the technological characteristics are minimal, and the associated procedures are nearly identical. The indications for use are identical to the indications of one of the previously cleared predicate devices.
The device, as designed, is as safe and effective as the predicate devices, and the device is substantially equivalent to the referenced predicate devices.
0000003
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized representation of three wavy lines, which are likely meant to symbolize the department's mission of promoting health and well-being. The seal is simple and professional in design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 8 2004
Mr. René van de Zande Official Correspondent Emergo Group, Inc. 2454 McMullen Booth Road, Suite 427 CLEARWATER FL 33759
Re: K032091
Trade/Device Name: Smart Klamp® Circumcision Clamp Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: 85 HFX Dated: December 9, 2003 Received: December 9, 2003
Dear Mr. van de Zande:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,
2
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in your 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 the 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" (21CFR Part 807.97) you may obtain. 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
3
Page 1 of 1
| 510(k) Number (if known): | K032091 |
|---|---|
| --------------------------- | --------- |
Device Name: Smart Klamp®
Indications for Use:
Circumcision of newborns and older males, defined as circumferential excision of the foreskin or prepuce at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K032091
(Optional Format 3-10-98)
ﻟﺴﻴﺔ -
(Posted July 1, 1998)