K993699 · Mid-Atlantic Diagnostics, Inc. · MQH · May 16, 2000 · Obstetrics/Gynecology
Device Facts
Record ID
K993699
Device Name
THE STRIPPER
Applicant
Mid-Atlantic Diagnostics, Inc.
Product Code
MQH · Obstetrics/Gynecology
Decision Date
May 16, 2000
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 884.6130
Device Class
Class 2
Indications for Use
"THE STRIPPER®" micropipette family's indication for use is to manipulate and transfer zygotes and embryos during IVF and ICSI procedures. "THE STRIPPER®" micropipettes are used in the tissue culture techniques performed by embryologists when preparing oocytes for IVF, ICSI and assisted hatching techniques prior to re-implantation. "THE STRIPPER®" micropipettes are tools used in procedures that have been developed to aid infertile couples achieve pregnancy. REMOVES CUMULUS AND CORONA CELLS FROM OOCYTE FOR CONFIRMATION OF FERTILITY DURING IVF. REMOVES CUMULUS AND CORONA CELLS FROM OOCYTE PRIOR TO ICSI PROCEDURES. USED TO TRANSFER EMBRYOS AND OOCYTES THROUGH VARIOUS MEDIA AND SOLUTIONS DURING THE IVF PROCEDURE.
Device Story
Hand-held manual micropipetter; aluminum barrel, stainless steel plunger, spring, o-rings, washer, collet. Uses polycarbonate tips of varying internal dimensions. Operated by embryologists in clinical laboratory settings. Creates vacuum to aspirate/dispense fluid and cellular material; used to remove cumulus/corona cells from oocytes and transfer embryos/oocytes through culture media. Facilitates IVF, ICSI, and assisted hatching procedures. Benefits patients by enabling precise handling of gametes and embryos during fertility treatments.
Clinical Evidence
Bench testing only. Toxicity assessed via one-cell mouse embryo bioassay (target >70% development to blastocyst at 96 hours). Endotoxin levels verified via Limulus Amebocyte Lysate assay (<0.03 EU/ml). Sterility validated per USP 23(71) via gamma irradiation (15-25 kGy) to achieve SAL 10^-6.
Indicated for use by embryologists to manipulate and transfer zygotes, embryos, and oocytes during IVF, ICSI, and assisted hatching procedures for infertile couples.
Regulatory Classification
Identification
Assisted reproduction microtools are pipettes or other devices used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods.
Special Controls
*Classification.* Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when the assisted reproduction microtools (pipettes) are manufactured from glass, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Submission Summary (Full Text)
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## ATTACHMENT I
## 510(K) SUMMARY Mid-Atlantic Diagnostics, Inc. - "THE STRIPPER®"
This 510(K) Summary of safety and effectiveness for the Mid-Atlantic Diagnostics, Inc. "THE STRIPPER®" is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
Applicant: Mid-Atlantic Diagnostics, Inc.
- Address: 338 Stokes Road Medford, NJ 08055
Contact Person: Terrance J. Fortino, President
Telephone #: (609) 953-3380
Fax #: (609) 953-3286
Preparation Date: October 29, 1999
Device Trade Name: "THE STRIPPER®" Micropipetter and Micropipetter Tips
Common Name: Micropipettes used for IVF
Classification Name: Assisted Reproduction Microtools (per 21 CFR 884.6130) 85-MQH
Substantial Equivalence: Substantial equivalence is being supported by the Federal Register Notice Final Rule entitled "Obstetric and Gynecologic Devices; Reclassification and Classification of Medical Devices Used for In Vitro Fertilization and Related Assisted Reproduction Procedures. This equivalence is supported by the Summary statement:
> Upon the effective date, the Federal Register document may be cited in the absence of an existing predicate device which would be used to support substantial equivalence.
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## Description of Mid-Atlantic Diagnostics, Inc. "THE STRIPPER®:
"THE STRIPPER®" micropipetter is a hand held device used to create the vacuum necessary for "THE STRIPPER®" micropipetter tips to aspirate and dispense fluid and cellular material. Its' components include an aluminum barrel that houses a stainless steel plunger and spring, an aluminum plunger shaft with finger pad, o-rings, washer and collet for securing "THE STRIPPER®" tips. (See Attachment III - "THE STRIPPER®" Spec Sheet)
"THE STRIPPER®" micropipette tips are fabricated from polycarbonate tubing wherein one end of the tube is pulled to a much smaller dimension to produce tips of varying internal dimensions.
#### Testing Procedures:
Each lot of micropipettes is mouse embryo tested for toxicity using a onecell mouse embryo bioassay. The assay is performed utilizing freshly collected embryos and culturing them in HTF medium supplemented with 0.4% BSA which was exposed to the test article. The extracted test media and non-extracted HTF medium (control) is placed in a culture dish in triplicate microdrops and overlaid with light mineral oil. The dish is allowed to equilibrate in an atmosphere of 5% CO2 at 30°C for a minimum of 2 hours. Following equilibration, the embryos are added to both the test and control medium and returned to the incubator. Embryo development is noted at 24 and 96 hours. Test articles that score > 70% development to blastocyst at 96 hours are considered non-toxic. A score of > 70% to blastocyst in the control medium indicates a valid assay.
Sterilization is performed by gamma irradiation. The sterilization validation program follows the United States Pharmacopeia 23(71) procedure. It is justified due to a low bioburden and every lot being validated for sterility. The sterility assurance level for the micropipette is 106.
The minimum established radiation dose is 15 kGy established by AAMI Method I, SIP. The maximum radiation dose is 25 kGy.
Each lot of micropipettes is also tested for endotoxin levels using the Limulus Amebocyte Lysate assay. The level of endotoxin units per device must be less than 0.03 EU/ml to be considered acceptable.
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### Intended Use Statement:
"THE STRIPPER®" micropipette family's indication for use is to manipulate and transfer zygotes and embryos during IVF and ICSI procedures.
"THE STRIPPER®" micropipettes are used in the tissue culture techniques performed by embryologists when preparing oocytes for IVF, ICSI and assisted hatching techniques prior to re-implantation.
"THE STRIPPER®" micropipettes are tools used in procedures that have been developed to aid infertile couples achieve pregnancy.
Performance Standards: Not Applicable
- Conclusion: Mid-Atlantic Diagnostics, Inc. "THE STRIPPER®" Micropipetter and Micropipette Tips are substantially equivalent to other existing micropippette tools used in the IVF procedure.
Additional Information: None requested at this time
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
**MAY 16 2000**
Mr. Terrance J. Fortino President MidAtlantic Diagnostics, Inc. 338 Stokes Road, Suite E Medford, NJ 08055
Re: K993699 The Stripper® Assisted Reproduction Microtool Dated: February 10, 2000 Received: February 16, 2000 Requiatory Class: Il 21 CFR §884.6130/Procode: 85 MQH
Dear Mr. Fortino:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 26, 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, 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Premattet Approval), 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 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulator, In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D.
Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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# INDICATION FOR USE STATEMENT
**510(K) NUMBER:** K993699
DEVICE NAME: MID-ATLANTIC DISGNOSTICS, INC. "THE STRIPPER®"
INDICATIONS FOR USE:
"THE STRIPPER®" MICROPIPET FAMILY'S INDICATION FOR USE IS T0 MANIPULATE AND TRANSFER ZYGOTES AND EMBRYOS DURING IVF AND ICSI PROCEDURES.
"THE STRIPPER®" MICROPIPETS ARE USED IN THE TISSUE CULTURE TECHNIQUES PERFORMED BY EMBRYOLOGISTS WHEN PREPARING OOCYTES FOR IVF, ICSI AND ASSISTED HATCHING TECHNIQUES PRIOR TO RE-IMPLANTATION.
"THE STRIPPER®" MICROPIPETS ARE TOOLS USED IN PROCEDURES THAT HAVE BEEN DEVELOPED TO AID INFERTILE COUPLES ACHIEVE PREGNANCY.
REMOVES CUMULUS AND CORONA CELLS FROM OOCYTE FOR CONFIRMATION OF FERTILITY DURING IVF.
REMOVES CUMULUS AND CORONA CELLS FROM OOCYTE PRIOR TO ICSI PROCEDURES.
USED TO TRANSFER EMBRYOS AND OOCYTES THROUGH VARIOUS MEDIA AND SOLUTIONS DURING THE IVF PROCEDURE.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
PRESCRIPTION USE L (PER 21 CFR 801.109)
OVER THE COUNTER USE
Urint M. Regerson
(Division Sign-Off)
OR
Division of Reproductive, Abdominal, E. and Radiological Deyices
510(k) Number K993699
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
